Aesthetic method of biological structure treatment by magnetic field

ABSTRACT

In methods for treating a patient, a time varying magnetic field is applied to a patient&#39;s body and causes a muscle contraction. The time-varying magnetic field may be monophasic, biphasic, polyphasic and/or static. The method may reduce adipose tissue, improve metabolism, blood and/or lymph circulation. The method may use combinations of treatments to enhance the visual appearance of the patient.

CROSS-REFERENCE

This application is a continuation of U.S. patent application Ser. No.16/827,330, filed Mar. 23, 2020, which is a continuation of U.S. patentapplication Ser. No. 15/601,719, filed May 22, 2017, which claimspriority to each of U.S. Provisional Patent Application Nos. 62/357,679,filed Jul. 1, 2016, 62/440,905, filed Dec. 30, 2016, and 62/440,922,filed Dec. 30, 2016. Each of these applications is incorporated hereinin its entirety by reference thereto.

FIELD OF THE INVENTION

The present invention generally relates to methods using the influenceof magnetic and induced electric field on biological structure. Themagnetic field is time-varying and high powered therefore the method isbased on a value of magnetic flux density sufficient to induce at leastpartial muscle contraction.

BACKGROUND OF THE INVENTION

Aesthetic medicine includes all treatments resulting in enhancing avisual appearance and satisfaction of the patient. Patients want tominimize all imperfections including body shape and effects of naturalaging. Indeed, patients request quick, non-invasive procedures providingsatisfactory results with minimal risks.

The most common methods used for non-invasive aesthetic applications arebased on application of mechanical waves, e.g. ultrasound or shock wavetherapy; or electromagnetic waves, e.g. radiofrequency treatment orlight treatment, such as intense pulsed light or laser treatment. Theeffect of mechanical waves on tissue is based especially on cavitation,vibration and/or heat inducing effects. The effect of applications usingelectromagnetic waves is based especially on heat production in thebiological structure.

Skin tissue is composed of three basic elements: epidermis, dermis andhypodermis or so called subcutis. The outer and also the thinnest layerof skin is the epidermis. The dermis consists of collagen, elastictissue and reticular fibers. The hypodermis is the lowest layer of theskin and contains hair follicle roots, lymphatic vessels, collagentissue, nerves and also fat forming a subcutaneous white adipose tissue(SWAT). The adipose cells create lobules which are bounded by connectivetissue, fibrous septa (retinaculum cutis).

Another part of adipose tissue, so called visceral fat, is located inthe peritoneal cavity and forms visceral white adipose tissue (VWAT)located between parietal peritoneum and visceral peritoneum, closelybelow muscle fibers adjoining the hypodermis layer.

Existing devices have low efficiency and they waste energy, which limitstheir use. Eddy currents induced within the coil create engineeringchallenges. Existing devices contain coils which are made of metallicstrips, electric wires or hollow conductors. Since the therapy requireslarge currents, significant losses are caused by induced eddy currentswithin the coil. Eddy currents lead to production of unwanted heat andtherefore there is need to sufficiently cool the coil. Also, the energysource must be protected during reverse polarity of resonance. Thisrequires using protective circuits which consume significant amounts ofenergy.

The currently used magnetic stimulation devices mostly consist of onemagnetic field generating device, a capacitor parallel to a power sourceand a switching device in series to the power source. Further suchtopology requires a snubbering device, such as diode or RC snubberingcircuit, for protecting the energy source during the reverse polarity ofresonance. The use of a snubbering device causes high energy losses. Themagnetic stimulation device wastes a lot of energy because of lowefficiency due to significant electric losses while generating thetime-varying magnetic field. Therefore these devices generate magneticimpulses ineffectively.

Current magnetic aesthetic methods are limited in key parameters whichare repetition rate and/or magnetic flux density. All known methods uselow values of magnetic flux density and/or low repetition rates whichdoes not allow satisfactory enhancement of visual appearance. As aresult, new methods are needed to enhance the visual appearance of thepatient.

Magnet therapy uses the influence of magnetic flux on biological tissue.Electric current is induced in the tissue due to voltage change whichcauses a polarization of the cell membrane. One of fundamentalphenomenon of electric current in biological tissue is a transfer ofneural excitation or muscle contraction. The intensity of the effect isdependent on the magnetic flux density, repetition rate of the pulses,pulse time duration or envelope of the stimulation signal.

The currently used aesthetic applications don't provide any treatmentcombining the effect of time-varying magnetic field treatment andconventional treatment, e.g. treatment by electromagnetic field such asradiofrequency treatment. The currently used radiofrequency treatmentincludes many adverse events such as non-homogenous thermal temperature,insufficient blood and/or lymph flow during and/or after the treatment.Additionally several adverse event such as panniculitis may occur afterthe treatment.

SUMMARY OF THE INVENTION

The present methods and devices as described below produce a timevarying magnetic field for patient treatment which better optimizesenergy use, increases the effectiveness of the treatments and provide anew treatment. The magnetic pulses may be generated in monophasic,biphasic or polyphasic regimes. In a first aspect, the device has one ormore coils; a switch; an energy storage device and a connection to anenergy source. The coil may be made of insulated wires with a conductordiameter less than 3 mm even more preferably less than 0.5 mm and mostpreferably less than 0.05 mm. Smaller diameter and individual insulationof the wires significantly reduces self-heating of the coil andtherefore increase efficiency of magnetic stimulation device. The coilmay be flexibly attached in a casing of device. The casing may comprisea blower or blowers which ensure cooling of the coil.

The present methods provide new aesthetic applications for focusedremodeling of the patient's body. The coil of the magnetic stimulationdevice may be flexibly attached to casing of the device. The blower orblowers may be arranged to blow air on both sides of coil. Optionally,the coil may be a flat type coil.

The method may provide a non-invasive transfer of a stimulation signalfrom an applicator to biological structure to evoke the action potentialof biological structure.

The method of treating a biological structure uses a combination ofnon-invasive methods for enhancing human appearance. The inventionutilizes electromagnetic field. Methods may be used for targetedremodeling of adipose tissue, focused treatment of cellulite, bodycontouring, skin tightening or skin rejuvenation. The invention relatesto focused heating of the target tissue by electromagnetic waves,whereas the effect of focused heating of the target tissue is amplifiedby the effect of a magnetic treatment.

In a first aspect, a method provides stimulation of biological structureusing magnetic field at repetition rates exceeding 50 Hz for purpose ofat least a partial muscle contraction.

In further aspect, a neuromuscular plate and/or the nerve innervatingthe neuromuscular plate is stimulated and at least partial musclecontraction is provided.

The magnetic treatment induces the muscle contraction at higherrepetition rates and the contraction is stronger. Therefore thetreatment is more efficient for reducing the number and/or volume ofadipocytes and enhancing the visual appearance of the treated bodyregion via targeted muscle contraction. Further the temperaturehomogeneity of is improved. Additionally, strong muscle contractions athigher repetition rates cause mechanical movement of all the layers inproximity of the contracted muscle. The methods therefore causeremodeling and/or neogenesis of the collagen and elastin fibers.

In another aspect, the stimulation utilizes non-invasive and/orcontactless transfer of the stimulation signal from an applicator tobiological structure to evoke the action potential of the biologicalstructure to induce at least partial muscle contraction. The applicatormay include a source of magnetic field e.g. a coil.

In another aspect of the invention the repetition rate may exceed thefrequency resolution of the structure. The magnetic flux density of thestimulation signal may increase over time. Therefore the envelope ofresulting stimulation signal is increasing and it is perceived by thestimulated biological structure as a continuous stimulation signalinstead of plurality of discrete stimuli. The envelope may be preferablytriangular and other shapes may be used as well. This method iseffective for stimulation of denervated muscle.

The envelope may be generated by time-varying magnetic flux densityand/or repetition rate and/or impulse duration.

The muscle tissue is selectively stimulated and the magnetic fluxdensity of the stimulation may be adjusted based on the patient'sfeeling and/or needs. Treatment time is shortened due to selectivestimulation of muscles. Additionally, the treatment may be non-invasiveor even contactless due to the high value of magnetic flux density.Invasive methods may be used as well. The patient may be treated withoutthe necessity of taking clothes off. The method reduces patientdiscomfort.

The present methods may be used for enhancing visual appearance of bodyareas including adipose tissue reduction, muscle toning, muscle shaping,body contouring, body shaping, skin tightening, cellulite treatment,circumferential reduction, breast enhancement and/or lip enhancement.

The methods enable new treatments by magnetic and/or electromagneticfield. The repetition rate of the magnetic field is in the range of 1 to300 Hz with high magnetic flux density up to 7 Tesla (equivalent to70000 Gauss). The frequency of the electromagnetic field is 13.56 or40.68 or 27.12 MHz or 2.45 GHz.

The present invention provides a new approach in determining theparameters of biological structure treatment.

According to the first aspect of the invention the magnetic stimulationdevice monitors the stimulation energy based on the current value of anoperation parameter and/or the operation parameter waveform of oneperiod.

According to still another aspect of the invention the control unit maycalculate optimal flow of the cooling medium based on the treatmentparameters, transition thermal characteristic of the magneticstimulation device and/or the cooling medium temperature andsignificantly reduce the noise of the cooling system.

According to still another aspect of the invention the control unit mayoptimize the treatment parameters based on the current value ofoperation parameters and a transition thermal characteristic of themagnetic stimulation device.

The present invention relates to device and methods for treating apatient by a magnetic and/or electromagnetic field. The application ofthe magnetic and/or electromagnetic field is provided by at least oneenergy delivery element. The device may be used for treatment or focusedremodeling of adipose tissue by reducing number and/or value oflipid-rich cells.

The present device and methods as described below provide combinedtreatment by high power magnetic and/or electromagnetic field,particularly radiofrequency treatment. The combined treatment may beprovided by one device using at least one coil for providing bothtreatments, the magnetic and even the electromagnetic treatment.

The device may include a plurality of energy delivery elements. Thepositioning of the plurality of the energy delivery elements may becontrolled by a mathematic method including monitoring a characteristicquantity of an operation parameter.

The energy delivery element may be used as an energy source for anotherfunctional part of an applicator, e.g. a blower, or for providing energyto light emitting device providing still another treatment.

Glossary

Conventional non-invasive and/or invasive aesthetic medicine treatmentmethods refer to aesthetic applications based on application ofmechanical waves, e.g. acoustic wave, ultrasound or shock wave therapy;or electromagnetic waves, e.g. radiofrequency or diathermy treatment orlight treatment, such as intense pulsed light or laser treatment; ormechanical stimulation, e.g. positive or negative pressure, rollerball,massage etc.; or thermal treatment, e.g. cryotherapy; or electrotherapymethod; or mesotherapy method and or any combination thereof.

Thermal treatment refers to treatment by heating or cooling, e.g. acryotherapy treatment.

Biological structure is at least one neuron, neuromuscular plate, musclefiber, adipose cell or tissue, collagen, elastin, pigment or skin.

Remodeling target biological structure refers to reducing the numberand/or volume of the adipocytes by apoptosis and/or necrosis, cellulitetreatment, body shaping and/or contouring, muscle toning, skintightening, collagen treatment, skin rejuvenation, wrinkle removing,reducing stretchmarks, breast lifting, lip enhancement, treatment ofvascular or pigmented lesions of the skin or hair removing.

Stimulation signal refers to a magnetic flux density inducing anelectric current in the biological structure.

Body region includes muscle or muscle group, buttocks, saddlebags, lovehandles, abdomen, hips, thighs, arms, limb and/or any other tissue.

Muscle includes at least one of muscle fiber, muscle tissue or group,neuromuscular plate or nerve innervating the at least one muscle fiber.

Deep muscle refers to a muscle that is at least partly below superficialmuscles and/or to the muscle that is covered by a thick layer of othertissue, e.g. mostly adipose tissue and/or the skin, with thickness 0.5,1, 2, 3, 4, 5 or more centimetres.

Adipose tissue refers to at least one lipid rich cell, e.g. adipocyte.

Bolus refers to a layer of fluid material, e.g. water or fluid solutionof ceramic particles, preferably enclosed in a flexible sac made ofbiocompatible material.

Impulse refers to a single magnetic stimulus.

Pulse refers to a period of treatment by a magnetic field of at leastone magnetic stimulus and time duration of no stimulation, i.e. timeduration between two impulses from rise/fall edge to next rise/falledge.

Repetition rate refers to frequency of firing the pulses; it is derivedfrom the time duration of a pulse.

Envelope refers to shape of curve created by connection of inducedenergy amplitudes stimulating the target biological structure.

Neural structure includes at least one neural cell, a neuron, aneuroglia, a Schwann cell, a nerve, a neural tissue, spine or brain.

Operation parameter refers to voltage, current or magnetic flux density.

Induced energy refers to energy stimulating the target neural structure,the amount of induced energy corresponds to repetition rate, magneticflux density and impulse duration.

Hardware panel refers to at least one hardware component used forcontrolling the optical and/or magnetic treatment. The hardware panelincludes at least one of input interface for inputting treatmentparameters by an operator and processing unit for controlling theoptical and/or magnetic treatment.

Treatment parameters refer to one or more of: magnetic flux density,repetition rate, impulse duration, wavelength, power flux density and/orenergy flux density of the optical waves, pulse width, modulation,treatment protocol or treatment duration.

Optical waves include electromagnetic waves from ultraviolet, visibleand infrared spectrum ranges, i.e. the waves of wavelength in the rangeof 190 to 13000 nm.

Optical waves generating device refers to laser or laser diode, lightemitting diode (LED), electric discharge source, incandescent source,fluorescent source, luminescent source, electroluminescent source etc.

Optical treatment refers to treatment by optical waves.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross section view of a coil winding.

FIG. 2A is a cross-section of a magnetic applicator.

FIG. 2B is an illustrative embodiment of cross-section of the magneticapplicator.

FIG. 3 is a side view of a casing of a magnetic applicator.

FIGS. 4A and 4B illustrate circuits for providing high power pulses to astimulating coil.

FIG. 5A illustrates an operation mode when impulses are generated by theplurality of magnetic field generating devices at one time within apulse.

FIG. 5B illustrates an operation mode when impulses are generated by theplurality of magnetic field generating devices at plurality of differenttimes within a pulse.

FIG. 6 illustrates an exemplary embodiment of a magnetic stimulationdevice including a plurality of magnetic field generating devicesgenerating time-dependent impulses.

FIG. 7 illustrates an exemplary embodiment of a magnetic stimulationdevice including a plurality of magnetic field generating devicesgenerating time-independent impulses.

FIG. 8 illustrates an exemplary embodiment of a magnetic stimulationdevice including a plurality of magnetic field generating devicesgenerating time-independent impulses.

FIG. 9 is a graph showing voltage drop in the energy storage device.

FIG. 10 illustrates a threshold value corresponding to differentenvelopes of the stimulation signal.

FIGS. 11A and 11B illustrate a detail of a stimulation signal withincreasing envelope,

FIGS. 12A and 12B illustrate a detail of a stimulation signal withincreasing envelope.

FIGS. 13A and 13B illustrate a detail of a stimulation signal withincreasing envelope.

FIG. 14 is a diagram of a biological effect.

FIG. 15 illustrated a stimulation by exemplary clusters.

FIGS. 16A and 16B illustrate diagrams of a treatment device.

FIG. 17 illustrates a general principle of a treatment device.

FIG. 18 illustrates a block diagram of treatment device including oneenergy delivery element.

FIGS. 19A and 19B illustrate an energy delivery element used as a powersupply for at least one electric component.

FIG. 20 illustrates an energy delivery element including a magneticcore.

FIGS. 21A and 21B illustrate an energy delivery element encircled by atleast one electrode.

FIGS. 22A and 22B illustrate exemplary embodiments connected by coil orcapacitor.

FIGS. 23A and 23B illustrate at least one electrode encircled by anenergy delivery element.

FIG. 24 illustrates a block diagram of treatment device includingtransmatch.

FIGS. 25A and 25B illustrate a block diagram of exemplary embodimentsincluding a plurality of energy delivery elements.

FIGS. 26A and 26B illustrate exemplary embodiments including a pluralityof energy delivery elements with phase shift.

FIG. 27 is a schematic diagram of a system for controlled deep heatingof sub dermal tissues.

FIG. 28 is a schematic view of a trans-regional course ofelectromagnetic field.

FIG. 29 illustrates a combined treatment administered by two separatedevices.

FIGS. 30A and 30B illustrate a combined treatment administered by onedevice including a plurality of applicators comprising magnetic fieldgenerating device or optical waves generating device.

FIGS. 31A and 31B illustrate a combined treatment by one deviceincluding one applicator comprising at least one magnetic fieldgenerating device and at least one optical waves generating device.—

FIGS. 32A and 32B illustrate a combined treatment with optical wavesgenerating device powered by magnetic field generated by magnetic fieldgenerating device.

DETAILED DESCRIPTION

The present invention provides a magnetic stimulation device and methodof controlling the magnetic stimulation device using a plurality ofmagnetic field generating devices.

The magnetic stimulation device may include the at least one applicator,the at least one energy source and at least two magnetic fieldgenerating devices. However, in an alternative embodiment the magneticstimulation device may include a plurality of applicators and/orplurality of energy sources. The plurality of applicators may be usedfor treatment of at least two cooperating muscle groups with differenttreatment effects. In an exemplary application e.g. the triceps brachiimuscle may be treated to achieve myostimulation effects and the bicepsbrachii muscle may be treated to achieve myorelaxation effects.

The magnetic stimulation device may include a plurality of applicators.The applicator includes at least one magnetic field generating devicewhich may be movable. The benefit of this embodiment is that themovement and/or positioning of the plurality of the applicators may beindependent. Hence different parts of the patient's body may be treatedsimultaneously. Therefore the total treatment time is reduced andpatient's downtimes are reduced as well. The movement of the at leastone applicator may be automatic so that manual manipulation may not beneeded. The movement of the at least one applicator may follow apredetermined trajectory or it may be random. In an alternativeembodiment the movement of the plurality of applicators may besynchronized.

The plurality of applicators may be positioned with respect to eachother in one plane; in at least two mutually tilted planes defined byconvex or concave angles, or perpendicular to each other; or in at leasttwo parallel planes. The angles of the planes may be adjusted by anoperator following the patient's needs. In an alternative embodiment thepatient may be positioned in the intersection of the magnetic fieldsgenerated by the plurality of magnetic field generating devices.

The benefit of this application may be treatment of a plurality ofcooperating muscles, such as agonist and antagonists, e.g. one musclemay be stimulated to achieve strengthening effect and on the other sidethe other muscle may be stimulated to achieve myorelaxation effect.

Using a plurality of magnetic field generating devices provides fastertreatment. Large and/or different areas may be treated in shorter time.Using a plurality of applicators allows different areas and/or targetbiological structures to be stimulated at the same time. The movement ofthe at least one applicator may automatically follow a predeterminedtrajectory. Hence manual manipulation is not needed. Furthermore theshape of the generated magnetic field may be adjusted by an operator.

The applicator including a coil which is preferably flat for magnettherapy is placed proximate to the patient's body. The magnetic flux isapplied into the biological structure. The electric current is inducedand stimulates the neuromuscular plate. Due to the stimulation at leasta partial muscle contraction is caused.

In one aspect of the invention a magnetic stimulation device includes atleast one applicator and a plurality of magnetic field generatingdevices. The magnetic field generating device may be air-cooled orcooled by any other fluid media.

Repetition rate and/or magnetic flux density may vary during thetreatment protocol. Further the magnetic stimulation signal may includeseveral periods of stimulation signal of different repetition rates,therefore the modulation of the signal is in repetition rate domain. Thestimulation signal may include several periods of stimulation signal ofdifferent magnetic flux densities, therefore the modulation of thesignal is in magnetic flux density domain. In yet another approach theenvelope of the stimulation signal may be modulated by combinations ofrepetition rate domain, magnetic flux density domain or impulse durationdomain.

Various envelopes of the stimulation signal and waveform, e.g. pulse,sinusoidal, rectangular, square, triangular, saw-tooth, trapezoidal,exponential etc. for the purpose of muscle stimulation may also be used,and is not limited to recited shapes of stimulation signals.

A magnetic treatment device may include at least one energy sourceand/or connection to the energy source, at least one switching device,at least one energy storage device, e.g. a capacitor, and at least onemagnetic field generating device e.g. a coil.

The magnetic stimulation device may include at least one energy source,at least one energy storage device (e.g. a capacitor), at least onemagnetic field generating device (e.g. a coil) and at least oneswitching device. The magnetic field generating device may include acore, however in a preferred embodiment the magnetic field generatingdevice includes no core. The switching device may be any kind of switchsuch as diode, MOSFET, JFET, IGBT, BJT, thyristor or a combination ofthem.

The at least one magnetic generating device may be in various shapes toenhance a variability of magnetic field profile. The shape of themagnetic field generating device may be circular, semicircular,rectangular, “FIG. 8”, V-shape, Y shape or a butterfly shape. Themagnetic field generating device may be flat (2-D shape). In analternative embodiment the magnetic field generating device maycorrespond to various 3-D bodies, e.g. a hemisphere. In anotheralternative embodiment the magnetic field generating device may beflexible to be better fitted to the patient. The magnetic fieldgenerating device may or may not include a core for the field shaping.

Large areas may be stimulated by the plurality of the magnetic fieldgenerating devices. The plurality of magnetic field generating devicesmay generate a plurality of independent magnetic fields, e.g. twomagnetic field generating devices may generate two magnetic fields withtwo peaks of magnitude of magnetic flux density.

The plurality of magnetic field generating devices may be operated atvarious treatment parameters and/or operation modes to provide varioustreatment effects for the patient during the treatment, e.g.myostimulation, myorelaxation, analgesic effect or aesthetic effectssuch as adipose tissue reduction, muscle toning, muscle shaping, bodycontouring, body shaping, skin tightening, cellulite treatment,circumferential reduction, breast enhancement and/or lip enhancement.

FIG. 1 illustrates a cross section of winding of a coil for a magneticstimulation device. The coil may be constructed from litz-wire, whereineach wire is insulated separately. Each individual conductor is coatedwith non-conductive material so the coil constitutes multiple insulatedwires. Unlike existing magnetic coil conductors, the present coil is notmade of bare wire e.g. litz-wire without insulation, or conductivetapes, conductive strips, or copper pipe with hollow inductors. Theinsulation of wires separately is a substantial improvement, since thisleads to a significant reduction of the induced eddy currents. Powerloss due to eddy currents, per single wire, is described by Equation 1below. The small diameter of wires significantly reduces self-heating ofthe coil and therefore increases efficiency of the present magneticstimulation device.

$\begin{matrix}{{P_{EDDY} = \frac{\pi^{2} \cdot B_{P}^{2} \cdot d^{2} \cdot f^{2}}{6 \cdot k \cdot \rho \cdot D}},} & {{Eq}.\mspace{14mu} 1}\end{matrix}$

where: P_(EDDY) is power loss per unit mass (W kg⁻¹); B_(P) is the peakof magnetic field (T); f is frequency (Hz); d is the thickness of thesheet or diameter of the wire (m); k is constant equal to 1 for a thinsheet and 2 for a thin wire; ρ is the resistivity of material (Ω·m); Dis the density of material (kg·m³).

The individual insulation of each wire reduces eddy currents. Theindividually insulated wires may be wound either one by one or in abundle of individually insulated wires so as to form a coil, which willserve as a magnetic field generator. The coil provides an improvement inthe efficiency of energy transfer in the LC resonant circuit and alsoreduces or eliminates unwanted thermal effects.

The coil may have a planar coil shape where the individually insulatedwires may have cross-section wires with conductor diameter less than 3mm even more preferably less than 0.5 mm and most preferably less than0.05 mm. The wires are preferably made of materials with higher densityand higher resistivity e.g. gold, platinum or copper. The diameters ofthe single wires should be minimal. On the other hand the total diametershould be maximal because of inverse proportion between thecross-section of all wires forming the coil and the electricalresistance. Therefore the ohmic part of the heat is then lower. Eq. 2describes power loss of the coil:

$\begin{matrix}{P_{R} = \frac{\rho \cdot \frac{l}{S} \cdot I^{2}}{m}} & {{Eq}.\mspace{14mu} 2}\end{matrix}$

Where: P_(R) is the power loss heat dissipation (W); ρ is the resistance(Ω·m); l is the length of wire (m); S is the surface area (m²); I is thecurrent (A) and m is 1 kg of wire material.

Total power loss is (Eq.3):

P _(TOT) =P _(EDDY) +P _(R).  Eq. 3

Where: P_(TOT) is the total power losses (W·kg⁻¹); P_(EDDY) is the powerdissipation of eddy currents (W·kg⁻¹); P_(R) is the power loss heatdissipation (W·kg⁻¹).

Dynamic forces produced by current pulses passing through the wires ofthe coil cause vibrations and unwanted noise. The individual insulatedwires of the coil may be impregnated under pressure so as to eliminateair bubbles between the individual insulated wires. The space betweenwires can be filled with suitable material which causes unification,preservation and electric insulation of the system. Suitable rigidimpregnation materials like resin, and elastic materials like PTE can bealso used. With the coil provided as a solid mass, the vibrations andresonance caused by movements of the individual insulated wires aresuppressed. Therefore noise is reduced.

The coil may be attached to the case of the applicator, such as a handheld applicator of the magnetic stimulation device; build-in applicatorin e.g. chair, bed; or stand-alone applicator e.g. on mechanicalfixture. The attachment may be provided by an elastic material e.g.,silicone, gum; or other flexible manner. Connection with the coil of theapplicator's case can be ensured by several points. The severalfastening points ensure the connection of the coil to the casing byflexible material so that the main part of the coil and the main part ofthe casing of applicator are spaced apart. The spacing should be atleast 0.1 mm so that air can easily flow. The gap between the coil andthe casing can be used either for spontaneous or controlled cooling. Thecoil may optionally be connected to the case of the applicator by onlyone fastening point. The fastening points eliminate vibrations of wireswhich could be transferred to housing of the applicator and thereforereduce noise of the magnetic stimulation device.

The magnetic stimulation device may be cooled by a fluid, e.g. by aliquid or a gas. In the preferred embodiment the magnetic stimulationdevice is cooled by air.

FIG. 2A is a cross-section of the magnetic applicator which allowsbetter flow on the lower and upper sides of the coil and thus moreefficient heat dissipation. The magnetic stimulation device includes acoil 1, the circuit wires 2 and the fastening points 3 for connection ofthe coil to the casing of the applicator (not shown). The fasteningpoints 3 are preferably made of flexible material however the rigidmaterial may be used as well. The fastening points 3 may be located onthe outer circumferential side of the coil. However, alternatively it ispossible to put these fastening points to a lower or upper side of thecoil.

The fastening points 3 connect the coil to the case of the applicator inat least one point. The fastening points 3 maintain the coil and themain part of the case of the applicator spaced apart so that fluid(which may be air or any liquid) can flow between them. At least oneblower 4 can be placed around the circumference of the coil, orperpendicular to the coil. The blower can be any known kind of devicefor directing the fluid e.g. outer air directed into the case of theapplicator. This arrangement of the blower allows air to bypass the coilfrom upper and lower (patient's) sides. In still another embodiment theouter air can be cooled before directing into the case. The blower canhave an inlet placed around the circumference of the coil for injectingair, to remove heat from the coil. A connecting tube (not shown) canensure connection of the applicator 5 with the energy source and/orcontrol unit of magnetic stimulation device. The connecting tube mayalso contain a conduit of the fluid.

The arrows 6 indicate the air flow through the applicator. Thisarrangement of the blower allows the air to bypass the coil from upperand lower (patient's) side. Outlet may be preferably placed on upperside of the casing. By placing the blower around the circumference ofthe coil instead of on the top/below the coil, the blower 4 does notinterfere with the magnetic flux peak and therefore its lifespan andreliability is increased.

FIG. 2B is a cross-section of the magnetic applicator which allowsbetter flow on the lower and upper sides of the coil and thus moreefficient heat dissipation. The magnetic stimulation device includes acoil 21, the circuit wires 23 and the fastening points 22 for connectionof the coil to the casing of the applicator (not shown). The fasteningpoints 22 are preferably made of flexible material however the rigidmaterial may be used as well. The fastening points 22 may be located onthe outer circumferential side of the coil. However, alternatively it ispossible to put these fastening points to a lower or upper side of thecoil.

The fastening points 22 connect the coil to the case of the applicatorin at least one point. The fastening points 22 maintain the coil and themain part of the case of the applicator spaced apart so that fluid(which may be air or any liquid) can flow between them. At least oneblower 24 can be placed around the circumference of the coil, orperpendicular to the coil. The blower can be any known kind of devicefor directing the fluid e.g. outer air directed into the case of theapplicator. This arrangement of the blower allows air to bypass the coilfrom upper and lower (patient's) sides. In still another embodiment theouter air can be cooled before directing into the case. The blower canhave an inlet placed around the circumference of the coil for injectingair, to remove heat from the coil. A connecting tube (not shown) canensure connection of the applicator 25 with the energy source and/orcontrol unit of magnetic stimulation device. The connecting tube mayalso contain a conduit of the fluid.

The arrows 26 indicate the air flow through the applicator 25. Thisarrangement of the blower allows the air to bypass the coil from upperand lower (patient's) side. Outlet may be preferably placed on upperside of the casing. By placing the blower around the circumference ofthe coil instead of on the top/below the coil, the blower 24 does notinterfere with the magnetic flux peak and therefore its lifespan andreliability is increased.

FIG. 3 is an illustrative embodiment of a casing of the magneticapplicator. The overview drawing contains casing itself 7, which mightcontain an outlet 8 preferably placed on upper side of the casing 7. Aconnecting tube 9 may not only ensure connection of the applicator withthe energy source and/or control unit of magnetic stimulation device,but also connection to a source of the fluid; however the conduit of thefluid 10 may also be connected separately.

In an alternative embodiment cooling may be provided by a member usingthermoelectric effect, e.g. a Peltier cooler. Alternatively, cooling maybe provided by Stirling engine cooling system.

FIG. 4A and FIG. 4B illustrate circuits for providing high power pulsesto the stimulating coil. FIG. 4A shows a circuit for providing highpower magnetic pulses. FIG. 4B shows a circuit for providing high powerpulses.

The state of art magnetic stimulation device achieves magnetic fluxdensity of a few tenths to several ones of Tesla (1 Tesla is equivalentto 10000 Gauss). To achieve this level of magnetic flux density, theenergy source used generates sufficient voltage. This voltage can reachthousands of volts. In FIG. 4A the circuits for providing high powerpulses to the stimulating coil contain a series connection to the switch11 and the coil 12. The switch 11 and the coil 12 together are connectedin parallel with an energy storage device 13. The energy storage device13 is charged by the energy source 14 and the energy storage device 13then discharges through the switching device 11 to the coil 12.

During second half-period of LC resonance, the polarity on the energystorage device 13 is reversed in comparison with the energy source 14.In this second half-period, there is a conflict between energy source14, where voltage on positive and negative terminals is typicallythousands of Volts. The energy storage device 13 is also charged to thepositive and negative voltage generally to thousands of Volts. As aresult, there is in the circuit, consequently, twice the voltage of theenergy source 14. Hence the energy source 14 and all parts connected inthe circuit are designed for a high voltage load. Therefore, theprotective resistors and/or protection circuitry 15 must be placedbetween energy source 14 and energy storage device 13. Disadvantage ofstate of art solution is large amount of energy transformed to undesiredheat in protective resistors and/or protection circuitry 15.

FIG. 4B shows a circuit for providing high power pulses for improvedfunction of the magnet stimulation device. The coil 16 and an energystorage device 17 are connected in series and disposed in parallel tothe switch 18. The energy storage device 17 is charged through the coil16. To provide an energy pulse, controlled shorting of energy source 19takes place through the switch 18. In this way the high voltage load atthe terminals of the energy source 19 during the second half-period ofLC resonance associated with known devices is avoided. The voltage onthe terminals of energy source 19 during second half-period of LCresonance is a voltage equal to the voltage drop on the switch 18.

The switch 18 can be any kind of switch such as diode, MOSFET, JFET,IGBT, BJT, thyristor or their combination. Depending on the type ofcomponent the load of energy source 19 is reduced to a few Volts, e.g.,1-10 volts. Consequently, it is not necessary to protect the energysource 19 from a high voltage load, e.g., thousands of Volts. The use ofprotective resistors and/or protection circuits is reduced oreliminated. The present designs simplify the circuits used, increaseefficiency of energy usage and provide higher safety.

The treatment by the magnetic stimulation device may be in differentoperation modes. One operation mode may generate a plurality of impulses51 at one time within the pulse 52 as illustrated in FIG. 5A. Anotheroperation mode may generate a plurality of the impulses 51 at differenttimes within the pulse 52 as illustrated in FIG. 5B. Both operationmodes may be combined.

The magnetic stimulation device may generate a plurality of the impulses51 by the magnetic field generation devices L₁, L₂, . . . L_(N) at onetime within the pulse 52. This operation mode is illustrated in FIG. 5A.As shown in FIG. 6, a magnetic stimulation device may include at leastone energy source 601, one energy storage device 602, N magnetic fieldgenerating devices 603-605 and N+1 switching devices 606-609, wherein Nis positive integer greater than 1. This exemplary embodiment includes aminimum of hardware components. The value of inductance of each magneticfield generating device may be constant, however in an alternativeembodiment different values of inductance may be used.

The switching device 607-609 may be switched separately, with themagnetic field generated by separate magnetic field generating devices.

In an alternative embodiment any switching device may be switched incombination with at least one other switching device.

The active magnetic field generating devices are the magnetic fieldgenerating device in the closed loop of the electric circuit. Forexample if the number of active magnetic field generating devices is 2and the inductances of the magnetic field generating devices are thesame, then the value of magnetic flux density for each magnetic fieldgenerating device is one-half of the magnetic flux density which wouldbe reached by one active magnetic field generating device with the sameparameters and conditions, e.g. inductance, resistance, frequency,voltage. The total equivalent inductance of the magnetic stimulationdevice may be changed by switching a plurality of switching devices intoa closed electric circuit. Therefore the impulse duration may beadjusted by adjusting the inductance. The value of total equivalentinductance (L_(total)) may be determined by Equation 4.

$\begin{matrix}{\frac{1}{L_{totl}} = {\frac{1}{L_{1}} + \frac{1}{L_{2}} + \cdots + \frac{1}{L_{N}}}} & {{Eq}.\mspace{14mu} 4}\end{matrix}$

The magnetic stimulation device may generate a plurality of impulses 51generated by the magnetic field generation devices L₁, L₂, . . . L_(N)at different times within the pulse 52. This operation mode isillustrated in FIG. 5B. This operation mode may multiply the repetitionrate perceived by the patient, e.g. when the number of magnetic fieldgeneration device is 3 and the repetition rate of each magnetic fieldgenerating device is 100 Hz, then the patient may perceive therepetition rate 300 Hz. In an alternative example, this operation modemay be used for treatments of high repetition rate when the magneticstimulation devices are switched to reach such repetition rates whichmay be sufficiently cooled.

In the example of FIG. 7 a magnetic stimulation device includes at leastone energy source 701, N energy storage devices 702-704, N magneticfield generating devices 705-707 and 2×N switching devices 708-713,wherein N is positive integer greater than 1. The at least one energystorage device 702-704 may be selectively charged by the energy source701 by selectively switching the switching devices 708, 710, 712 and theimpulses may be selectively generated by selectively switching theswitching devices 709, 711, 713.

The benefit of this exemplary embodiment is the time independency of theimpulses generated by the separate magnetic field generating devices.However, the switching devices may be synchronized to generate theimpulses at one fixed time within the pulse or both operation modes maybe combined using this embodiment. Another benefit of this embodiment isthe possibility of providing various treatments by a plurality ofmagnetic field generating devices. Various treatments may providevarious effects for the patient, e.g. stimulation, such asmyostimulation, pain alleviation or myorelaxation.

FIG. 8 illustrates an example where the magnetic stimulation deviceincludes N energy sources 801, N energy storage device 802, N magneticfield generating devices 803 and N switching devices 804, wherein N ispositive integer greater than 1. The at least one energy storage device802 may be selectively charged by the energy source 801 and the impulsesmay be selectively generated by selectively switching the switchingdevices 804.

The impulses generated by the separate magnetic field generating devicesare time independent. However, the switching devices may be synchronizedto generate the impulses at one time within the pulse or both operationmodes may be combined.

The inductance of magnetic field generating devices in each embodimentmay vary. The capacitance of the energy storage devices in eachembodiment may vary as well. The impulse duration may be variable and/orthe magnetic flux density generated by different magnetic fieldgenerating devices may vary as well.

FIG. 9 shows an exponential voltage drop in the energy storage device.Energy savings during time-varying magnetic therapy may be characterizedby reduced voltage drop in the energy storage device between the first,second and subsequent maximums of the resonant oscillation. Themagnitude of the individual voltage oscillations is exponentiallydampened up to establishing the energy balance. This allows increasingthe maximum possible frequency/repetition rate of magnetic pulses, sincethe frequency/repetition rate is dependent on the speed with which it ispossible to recharge the energy storage device. Since the energy storagedevice is recharged by the amount of energy loss during the previouspulse, it is possible to increase the frequency/repetition rate of thedevice up to hundreds of magnetic pulses per second without the need toincrease the input power. The voltage drop between any of the successiveamplitudes is not higher than 21%, even more preferably not higher than14% and most preferably not higher than 7%.

The device can be used for treatment/successive treatments in continual,interrupted or various duty cycle regime. The duty cycle may be higherthan 10%, which means interrupted regime with the ratio up to 1 activeto 9 passive time units. The ratio may possibly change during thetherapy. The device enables operation defined by the peak to peakmagnetic flux density on the coil surface at least 3 T, more preferablyat least 2.25 T, most preferably at least 1.5 T at repetition ratesabove 50 Hz, more preferably at repetition rates above 60 Hz, even morepreferably at repetition rates above 70, most preferably at repetitionrates above 80 Hz with treatment/successive treatments lasting severalseconds or longer, for example, for at least 5, 10, 30, 60, 120 or 240seconds, or longer. The total power consumption is below 1.3 kW and thewidth of pulses is in the range of hundreds of μs.

The device enables achieving repetition rates above 100 Hz, morepreferably repetition rates above 150 Hz, most preferably repetitionrates above 200 Hz with the magnetic flux density providing atherapeutic effect on neurons and/or muscle fibers and/or endocrinecells (e.g. at least partial muscle contraction, action potential incell). Based on achievement of repetition rates in order of few hundredsthe device also enables assembling the magnetic pulses into the variousshapes (e.g. triangular, rectangular, exponential), with the shapewidths from 6 ms to several seconds or longer.

Alternatively the magnetic field generating device may generate a staticmagnetic field. The magnetic field generating device generating thestatic magnetic field may be e.g. a permanent magnet or electromagnet.The coil may be powered by a power source, a transformer and/or anenergy storage device. The magnetic field may be applied as time-varyingmagnetic field by movement of the magnetic field generating device.Alternatively the magnetic field generating device may be switched onand off.

During last few decades patient have not only wanted to be in goodhealth, they have also wanted to look well, i.e. to be well shaped,without any unattractive fat and to have a young appearance, withoutwrinkles, stretchmarks or sagging breasts. This has resulted in aprogressive evolution of invasive aesthetic methods such as surgicalremoving of fat and remodeling the human body by invasive andpotentially dangerous methods, e.g. liposuction or inserting implantsinto human body. The side effects of invasive methods may be scars,swelling or bruising. The side effects resulted in the rapid progress innon-invasive method, e.g. lipolysis or removing skin imperfections. Oneexample of the last few years may is rapid increase of patients' demandfor enhancing the visual appearance of buttocks. This has resulted in ahigher percentage of these operations by plastic surgeons.

Electric current may be induced in the treated biological structureduring pulsed magnetic treatment. Due to the high value of magnetic fluxdensity the biological structure may be targeted and treated morespecifically. A distribution of magnetic field is uniform in thebiological structure. Particles (e.g. atoms, ions, molecules etc.) inthe biological structures are influenced by the magnetic field andpermeability of a cell membrane may also increase.

Due to increased permeability of the cell membrane, the pulsed magnetictreatment may induce following effects: at least partial musclecontraction; reduction of adipose tissue-volume and/or number of theadipose cells; neogenesis and/or remodeling of collagen and/or elastinfibers. Further magnetic treatment may improve circulation of bloodand/or lymph and improve local and/or adipose tissue metabolism.

With the present methods, factors for enhancing visual appearance of thebody include: treatment of major muscle, e.g. gluteus maximus; treatmentof deep muscle which may be enabled by high value of magnetic fluxdensity; non-contact application of magnetic flux density, it may beapplied even through clothing; stronger muscle contraction due to highervalue of magnetic flux density; higher-quality of muscle targeting;treatment may not be influenced by small movements during treatment;treatment time duration may be shortened due to high value of magneticflux density and/or higher repetition rate; no delays may occur.

It is to be understood that the method is not limited to the particularapplications and that the method may be practiced or carried out invarious ways.

Present method may be applied for enhancing the visual appearance ofbody parts including or proximate to major muscle structures. Furtherthe method may be applicable for enhancing the visual appearance ofpatients with high value of BMI. A patient with BMI of at least 18,preferably at least 25, more preferably at least 30, most preferably atleast 35 or more may be preferably treated by the recited methods. Thethickness of patient's SWAT and/or VWAT may be at least 0.1, 0.5, 10,15, 25, 50, 75, 100 or more. The patient may be preferably healthywithout any life-threatening conditions such as circulatory systemdisease, e.g. deep vein thrombosis. The present method is not limited tothe application of the treatment to major muscle. Muscles other thanmajor muscles may be treated as well.

The applicator of magnetic treatment may be placed proximate to thepatient's body. As used here, proximate to includes both contactless andin actual contact with the skin of the patient. The muscles may beselectively treated and the magnetic flux density may be adjustedfollowing the patient's feeling or needs. The treatment time may beshortened due to selective treatment of the correct muscles.Additionally, due to the high value of magnetic flux density, the musclemay be treated more effectively. Further, the treatment may benon-invasive or even preferably contactless due to the high value ofmagnetic flux density. The patient may be treated without removingclothing, reducing patient discomfort. Additionally, following the highefficiency of the muscle contraction the collagen and/or elastin fibersabove the muscle structure may be remodeled, hence the visual appearancemay be enhanced.

The collagen constitutes around 30% of proteins. Treatment bytime-varying magnetic field may induce the neocollagenesis. The collagenmay be treated by various repetition rates, e.g. in the range of 1 to250 Hz, more preferably in the range of 10 to 100 Hz, or up to 700 Hz.However, the repetition rate of 25 Hz may be preferably used because theresults achieved by stimulation of repetition rate of 25 Hz were themost significant. High value of magnetic flux density may improve theneocollagenesis more than low value of magnetic flux density. Hence themagnetic flux density may be at least 0.5 T, more preferably 1 T, mostpreferably at least 2 T, or up to 7 T.

The position of the patient may correspond to treated biologicalstructure and/or body region. The patient may be treated in seatedposition. Alternatively, the patient may be treated in lying position,e.g. in supine position. Treatment in lateral recumbent position may bealso applicable. Patient may be in prone position as well.

In the preferred application the treatment method may be applied to bodyregions prone to cellulite and/or prone to adipose accumulation, such asthighs, saddlebags, buttocks, abdomen, region of love handles, region ofbra fat or arm. The adipose accumulation may be influenced by numberand/or volume of adipose cells.

The magnetic treatment of the biological structure may have variousapplications for enhancing visual appearance of the contour of a bodyregion. High density magnetic field reaching such values which may beused for: adipose tissue reduction, wherein the adipose tissue reductionmay be achieved by reduction of number and/or volume of adipose cells;muscle toning, wherein the muscle appearance enhancement may be achievedby adipose tissue reduction with no muscle bulking; muscle shaping,wherein the muscle appearance enhancement may be achieved by adiposetissue reduction and/or muscle bulking; body contouring, wherein thesilhouette appearance enhancement may be achieved by adipose tissuereduction with no muscle bulking; body shaping, wherein the silhouetteappearance enhancement may be achieved by adipose tissue reductionand/or muscle bulking; skin tightening, wherein the skin appearanceenhancement may be achieved by obtaining smoother and youngerappearance, including wrinkles reduction; cellulite treatment, whereinthe appearance enhancement may be achieved by adipose tissue reduction,muscle contraction and/or elastic fibers neogenesis; circumferentialreduction, wherein the reduction may be achieved by adipose tissuereduction and/or the muscle bulking; breast enhancement, wherein theappearance enhancement effect may be achieved by elevation or shapemodification; lip enhancement, wherein the lip appearance enhancementmay be achieved by obtaining fuller and firmer appearance. The bodyregion may be reduced in overall size. Further aesthetic effects may beachieved, e.g. connective tissue improvement, fat disruption, musclevolumization, muscle forming, muscle toning, muscle remodeling,contouring, sculpting or body sculpting.

The one approach is stimulating central neural system or peripheralneural structure and determining the feedback, e.g. muscle contraction.

Neural system includes central neural system and/or peripheral neuralsystem.

In still another application of the invention, the time-varying magneticfield may be used for stimulation of neural structure to cause musclestimulation. The muscle stimulation may occur during stimulation byenvelopes of repetition frequencies below 100 Hz.

In the methods described, the magnetic stimulation device may or may notinclude a magnetic core. The magnetic stimulation device may be cooledby fluid, e.g. by air, water or oil. Total power consumption of themagnetic stimulation device may be below 1.3 kW. The power of themagnetic stimulation device may be at least 150, 250 or 500 W togenerate a magnetic flux density sufficient to induce at least musclecontraction. A magnetic stimulation device as described in the U.S.patent application Ser. No. 14/789,156 or U.S. patent application Ser.No. 14/789,658, incorporated herein by reference, may be used.

The applicator for magnetic treatment may be placed proximate to thepatient's body. The magnetic flux density may be applied into the targetbiological structure. Electric current may be induced and treat theneuromuscular plate and/or the nerve innervating the at least one musclefiber. The treatment may cause at least a partial muscle contraction.

FIG. 10 illustrates the different shapes of the envelope of thestimulation signal and corresponding different threshold values of ahealthy muscle. When the healthy muscle is stimulated by a rectangularenvelope 1001 of stimulation signal the muscle contraction occurs atmagnetic flux density A₁ 1002. When the healthy muscles is stimulated byincreasing envelope 1003 of stimulation signal the muscle contractionoccurs at magnetic flux density value A₂ 1004. However, when thedenervated muscle is stimulated by increasing envelope 1003 ofstimulation signal the denervated muscle contraction occurs at magneticflux densities below A₂ 1004. Magnetic flux density value A₂ 1004 is amultiplication of magnetic flux density value A₁ 1002, wherein themultiplication coefficient is positive number greater than 1.

The envelope may be generated on the basis that the biologicalstructure, e.g. a nerve or at least one muscle fiber, is not able todistinct single pulses during the stimulation at higher repetitionrates, e.g. exceeding 100 Hz, more preferably at least 150 Hz, even morepreferably at least 200 Hz, most preferably at least 250 Hz, or up to700 Hz.

Generally, at least two pulses are necessary to create a simple shape ofthe envelope, e.g. rectangular or trapezoid. However, the more complexenvelope shape is the more pulses are needed. The induced energy (IE)stimulating the target neural structure is a function of repetitionrate, magnetic flux density and/or impulse duration.

The envelope may consists of several impulses 51 called train. Thenumber of pulses in one train varies in a range of at least 2 pulses tothousands of pulses. The repetition frequency of envelope is given bythe envelope period, i.e. the envelope may include time with nostimulation as well. The envelope may consist of stimulation signalswith various burst frequencies, e.g. 5, 10, 20, 50, or more Hz. Theenvelope may be generated by several modulation approaches.

Envelope may be generated by time-varying magnetic field of varying peakmagnetic flux density hence the process is called magnetic flux densitymodulation (MFDM). The principle of MFDM is described in FIGS. 11A and11B. The repetition rate of the time-varying magnetic field is constanthence the period of the pulse is constant. The impulse duration remainsconstant as well. However, the magnetic flux density of each impulse 51varies with respect to the preceding impulse 51, as in FIG. 11A.Therefore each impulse magnetic flux density is different from magneticflux density of the preceding impulse. The principle is explained bytriangular shaped envelope 1101 as shown in FIG. 11B.

Alternatively the envelope may be generated in repetition rate domainhence the process is called repetition rate modulation (RRM). Theprinciple of RRM is described in FIGS. 12A and 12B. The magnetic fluxdensity of each impulse 51 remains constants. The impulse durationremains constant as well. Therefore the induced energy for one pulse isconstant. However, the repetition rate varies hence the time duration ofeach pulse varies with respect to the preceding pulse, see FIG. 12A. Theactual value of induced energy corresponds to the actual repetition rateof the time-varying magnetic field. When the repetition rate increasesthe value of induced energy increases or vice versa. The principle isexplained by triangular shaped envelope 1201, see FIG. 12B.

According to still another aspect of the application, envelope may begenerated in impulse duration domain. The principle of impulse durationmodulation is shown in FIGS. 13A and 13B where the magnetic flux densityand the repetition rate of time-varying magnetic field remains constant.However, the impulse 51 duration of each pulse varies as shown FIG. 13A.The principle is explained by triangular shaped envelope 1301 in FIG.13B.

The modulation approaches are not limited by exemplary waveform.Therefore the envelope may be rectangular, square, saw-tooth,trapezoidal, sinusoidal, exponential etc.

All the mentioned applications may be applied in constant repetitionrate and/or repetition frequency manner. The envelope modulation orcombination thereof is applicable as well.

Furthermore, the present invention discloses the advanced approaches inaesthetic applications, e.g. for cellulite treatment and/or bodyshaping. Combined methods of treatment by electromagnetic field andtreatment by magnetic field are used. The electromagnetic field mayinclude treatment by radiofrequency, infrared or optical waves. Themagnetic treatment may be provided by permanent magnets, electromagneticdevices generating a static magnetic field or time-varying magneticdevices. In the preferred application the treatment by a pulsed magneticfield and radiofrequency treatment may be combined. However theapplication is not limited by the recited combination so the combinedmethod may include magnetic treatment and any treatment byelectromagnetic field, e.g. light treatment, IR treatment or treatmentby radiofrequency waves, e.g. microwaves, short waves or long waves. Themagnetic treatment may also be provided with thermal treatment, e.g.heating and/or cooling.

A device described in U.S. patent application Ser. No. 14/278,756incorporated herein by reference may be used for application of thepresent methods. The device may exclude the balun transformer, or thebalun transformer may be included in transmatch. The possible methods oftreatment by combined methods are described below.

Magnetic treatment in combination with radiofrequency treatment may beapplied by two independent treatment devices, e.g. one device fortreating the biological structure by radiofrequency waves and seconddevice for treating the biological structure by magnetic field. Bothdevices may have a separate applicator for treating the biologicalstructure, or one applicator may be used by at least two devices, i.e.the applicator may be modular for a plurality of devices.

The device may include at least one HF frequency generator for providingenergy for radiofrequency treatment and for providing energy formagnetic treatment. In an alternative embodiment, the device may includeat least one HF frequency generator for providing energy forradiofrequency treatment and at least one other independent frequencygenerator for providing energy for magnetic treatment. The device mayinclude plurality of applicators for providing separate radiofrequencyor magnetic treatments to the patient.

In alternative embodiment the applicator may provide a combination ofradiofrequency and magnetic treatment. In one embodiment, the applicatormay include at least one radiofrequency electrode for providingradiofrequency treatment and at least one magnetic field generatingdevice, e.g. a coil, for providing magnetic treatment. In anotherembodiment, the applicator may include at least one electrode forproviding radiofrequency treatment and at least one magnetic fieldgenerating device providing magnetic treatment, wherein the at least oneRF source provides energy for both at least one electrode and at leastone magnetic field generating device.

In still another embodiment the at least one RF source may provide theenergy for the at least one magnetic field generating device providingmagnetic treatment wherein the at least one magnetic field generatingdevice may be used as the at least one electrode. The essence is the fardifferent stimulation frequencies which are used for RF treatment andmagnetic treatment. The magnetic field generating device in the highfrequency field is similar to the electrode. This enables the magneticfield generating device to be the electrode for radiofrequencytreatment. In the preferred embodiment a flat coil may be used as theelectrode.

The frequencies for the radiofrequency treatment may be in the range ofones of MHz to hundreds of GHz, more preferably in the range of 13 MHzto 3 GHz, most preferably around 13.56 or 40.68 or 27.12 MHz or 2.45GHz. The term “around” should be interpreted as in the range of 5% ofthe recited value. The impulse frequencies for the magnetic treatmentmay be in the range of hundreds of Hz to hundreds of kHz, morepreferably in the range of ones of kHz to tens of kHz, most preferablyup to 10 kHz. However the repetition rate of the magnetic impulses mayreach up to 700 Hz, more preferably up to 500 Hz, most preferably in therange of 1 to 300 Hz, e.g. at least 1, 5, 20, 30, 50, 100, 140 or 180Hz. The magnetic flux density of the magnetic treatment may be at least0.1, 0.8, 1, 1.5, 2, 2.4 or up to 7 Tesla on the coil surface(equivalent to 70000 Gauss). The treatment/successive treatments maylast several seconds, e.g. at least 5, 10, 30, 60, 120 or 240 seconds,or longer, e.g. at least 20, 30, 45, 60 minutes. The impulse durationmay be in the range of 3 μs to 10 ms or more, or alternatively 3 μs to 3ms or alternatively 3 μs to 1 ms. The impulse duration may be e.g. 3,10, 50, 200, 300, 400, 500, 625, 1000, 2000 or 3000 μs. The duty cycleof the stimulation may be at least 1:50, more preferably at least 1:40,even more preferably at least 1:20, most preferably at least 1:8 or upto 1:4. The magnetic stimulation device may emit no radiation.

A derivative of the magnetic flux density is defined by Equation 5.

$\begin{matrix}{\frac{dB}{dt},} & {{Eq}.\mspace{14mu} 5}\end{matrix}$

where: dB is magnetic flux density derivative [T]; dt is time derivative[s].

The maximal value of the magnetic flux density derivative may be up to 5MT/s, preferably in the ranges of 0.3 to 800 kT/s, 0.5 to 400 kT/s, 1 to300 kT/s, 1.5 to 250 kT/s, 2 to 200 kT/s, 2.5 to 150 kT/s. In exemplaryapplications the maximal value of the magnetic flux density derivativemay be at least 0.3, 0.5, 1, 2.5, 3.2, 5, 8, 10, 17, 30 or 60 kT/s. Thevalue of magnetic flux density derivative may correspond to inducedcurrent within the tissue.

The magnetic flux density derivative may be determined within the entireperiod of the magnetic signal and/or in any segment of the magneticsignal.

Alternatively the treatment device may include no deep muscle diathermydevice for heating the target biological structure. The treatmentpreferably may include no electrode which may enable heating thebiological structure in contact mode.

Cellulite is an effect of skin change resulting in orange peelappearance. The cause of the cellulite is orientation of collagen fibersin so called “fibrous” septae. The fibrous septae contract and hardenover time creating a dimple effect. Additionally, blood and lymphaticvessels lack circulation due to the contraction and hardening of theseptae. The lymph flow may be blocked resulting in swelling. Anothercause of cellulite may be adipose cells protruding to dermis. Cellulitemay be treated by the recited methods.

One application of time-varying magnetic field for enhancing the visualappearance of body region may be treatment of a muscle by magnetic fluxdensity for reducing the cellulite. The magnetic flux density may bedelivered through the skin to the neuromuscular plate and/or nerveinnervating at least one muscle fiber. The electric current may beinduced in the target biological structure causing at least partialmuscle contraction. The at least partial muscle contraction may causethe movement of the skin and all the biological structures subtendingepidermis. Additionally, the at least partial muscle contraction mayimprove blood circulation by itself, or via the movement of the musclein the vicinity including fibrous septae. Additionally, blood and/orlymph circulation may be improved in the layers subtending epidermissince the muscle contraction may move the fibrous septae. Also localand/or adipose tissue metabolism may be improved.

The magnetic treatment may be used for improving the lymph flow.

The lymph flow may be improved by at least partial muscle contractionwhich may provide effect similar to manual massage. The improved lymphflow may improve local metabolism and/or immune system. The improvedlymph flow may contribute to purer lymph due to faster delivery of thelymph to the lymph nodes where the lymph may be cleared.

The present method may provide a massage effect via the treatment whichmay be caused by the at least partial muscle contraction. Therefore themassage effect may be achieved by contactless methods instead of manualmassage techniques or soft tissue techniques. The massage effect mayimprove lymph circulation.

In another aspect, improvement of functionality and/or the appearance ofthe muscle may be achieved with results similar to body exercise. Theresults may be achieved by application of high magnetic flux density tothe body region and inducing at least partial muscle contraction. Highervalues of magnetic flux density applied may result in a stronger musclecontraction. The patient may feel firmer and tighter.

With the present method muscle contractions induced by the appliedmagnetic flux density may help to tone the muscle providing a moreattractive appearance. As the muscle structure is treated bytime-varying magnetic field the entire limb may be moved due to the highpower of the magnetic treatment. Nevertheless, the method is not limitedto the applications to the limbs and the method is able to treat anymuscle, e.g. gluteus maximus or any muscle/deep muscle to induce bodycontouring and/or body shaping effect and fat burn. Additionally,shortened and/or flabby muscles may be stretched. The physical fitnessof the patient may be improved as well.

The magnetic field may treat various body regions, e.g. thighs,buttocks, hips, abdomen or arms. The muscles may be shaped to enhancevisual appearance of the treated body region. The body part may obtainenhanced visual appearance of its contour.

The magnetic field may treat at least one muscle of lower limb,particularly the parts which are prone to cellulite such as thighs orsaddlebags. The time-varying magnetic field may induce at least partialmuscle contraction in different muscle and/or muscle group. Followingthe position and/or orientation of the magnetic field generating devicethe anterior, posterior and/or medial compartment of the thigh may betreated. The anterior compartment includes sartorius muscle, rectusfemoris muscle, vastus lateralis muscle, vastus intermedius muscle,vastus medialis muscle. Posterior compartment includes biceps femorismuscle, semitendinosus muscle and semimembranosus muscle. Medialcompartment includes pectineus muscle, external obturator muscle,gracilis muscle, adductor longus muscle, adductor brevis muscle andadductor magnus muscle.

The treatment may cause circumferential reduction of thighs. Further themuscle may obtain enhanced visual appearance, thigh may be well-shaped.Thigh contour may be enhanced as well.

The at least one surrounding body region may be treated as well, e.g.buttocks.

The ocular muscles may be treated by focused treatment of magnetic fluxdensity exceeding 0.1 T. The treatment may induce the at least partialmuscle contraction of the ocular muscle which may be exercised to bestrengthened.

The applicator may be placed within proximity of the patient's treatedarea. The applicator may be fixed to the patient. Alternatively thecorrect position may be provided by a mechanical arm and/or adjustableapplicator. The applicator may be made of adhesive and/or high frictionmaterial at least on contact surface with the patient.

The magnetic field may be generated with a low repetition rate such as 1Hz for a predetermined period of time, e.g. 30 seconds, sufficient forsetting the applicator to a correct position where the treatment is mosteffective. During the period the magnetic flux density may be adjustedfollowing the patient's needs to induce muscle contraction sufficientlystrong and comfortable for the patient.

The treatment may start a treatment protocol. The treatment protocol mayinclude a set of predetermined treatment sequences of predeterminedrepetition rates applied for predetermined time periods. The sequencesmay be repeated and/or adjusted following the patient's need. Thesequence may include a repetition rate in the range of 1 to 100 Hz,preferably in the range of 2 to 90 Hz, more preferably in the range of 5to 50 Hz, most preferably in the range of 10 to 45 Hz. The sequences maylast at least 30, 45, 60, 90, 120 or up to 300 seconds.

Alternatively the treatment may include the only the treatment protocolwithout applying the magnetic field of low repetition rate. The correctposition of the applicator and/or adjusting the magnetic flux densitymay be adjusted during the first sequence of the treatment protocol.

Repetition rate and/or magnetic flux density may vary during thetreatment protocol. Further the magnetic stimulation signal may includeseveral periods of stimulation signal of different repetition rates,therefore the modulation of the signal is in repetition rate domain. Thestimulation signal may include several periods of stimulation signal ofdifferent magnetic flux densities, therefore the modulation of thesignal is in magnetic flux density domain. In yet another approach theenvelope of the stimulation signal may be modulated by combinations ofrepetition rate domain and magnetic flux density domain.

In one application, the treatment may induce the same effect as muscleexercising of buttocks. During the treatment of buttocks the magneticfield may be targeted to treat of muscles shaping the buttocks, e.g.tensor fasciae latae muscle or at least one of gluteal muscles: maximus,medius or minimus. In one preferred application all three glutealmuscles may be treated. Further other muscles may be treated, e.g.abdominal muscles, spinal muscles and/or thoracic muscles. By thecomplex treatment and muscle contraction in the body region the treatedmuscles may be strengthened, toned, the cellulite may be reduced anddimples may be removed. Buttocks and even the patient's figure may beenhanced in visual shape appearance and may become more attractive.Buttocks become well-shaped, round, firm, well-trained, toned, smoother,tight and lifted. The complex treatment may reduce hips, make perfectround and lifted buttocks, increasing the self-confidence of thepatient.

The treatment may be more efficient than standard workout in fitnesssince the fitness machines strengthen only the isolated muscles. Theresults may be achieved in very short-time periods with minimal time oftreatment. Without being limited, it is believed that the exercising ofthe gluteus medius may reduce the volume of the buttocks; exercising ofthe gluteus maximus may shape and/or lift the buttocks; exercising ofthe gluteus minimus may lift the buttocks.

The magnetic treatment may also treat at least one surrounding bodyregion, e.g. thighs and/or saddlebags.

In the preferred application the magnetic treatment may be combined withother treatment methods using different approaches, e.g. conventionalnon-invasive treatments. The combined treatment may be applied to thesurroundings tissues around buttocks to reduce the cellulite around thebuttocks and enhance the shape of the enhanced appearance of thebuttocks. The surrounding tissues may be represented by e.g. abdomen,love handles, thighs or saddle bags.

The magnetic field may treat at least one muscle responsible forsilhouette of the body. The time-varying magnetic field may induce atleast partial muscle contraction in different muscle and/or muscle groupresponsible for silhouette in the region of abdomen, love handles and/orbra fat. Following the position and/or orientation of the magnetic fieldgenerating device rectus abdominis muscle may be treated. Alternativelylatissimus dorsi muscle, abdominal internal oblique muscle, abdominalexternal oblique muscle, transverse abdominal muscle and/or pyramidalismuscle may be treated by the time-varying magnetic field.

The treatment may cause circumferential reduction in the region ofbelly, hips and/or love handles. Alternatively the treatment may tightenat least one of these body parts. Further the muscles may obtainenhanced visual appearance, belly may be well-shaped. Repetitiveapplication may even reach in a six-pack look. The at least onesurrounding body region may be treated as well, e.g. buttocks.

The magnetic field may treat at least one muscle of upper limb,particularly the parts which may be prone to cellulite such as arm. Thetime-varying magnetic field may induce at least partial musclecontraction. Following the position and/or orientation of the magneticfield generating device the at least partial muscle contraction mayoccur in biceps brachii muscle, brachialis muscle, coracobrachialismuscle and/or triceps brachii muscle.

The treatment may cause circumferential reduction of the arm. Furtherthe muscle may obtain enhanced visual appearance, arm may bewell-shaped. Arm contour may be enhanced as well.

The at least partial muscle contraction may be more efficient foradipose tissue metabolism as the value of magnetic flux densityincreases since the muscle contraction may be stronger. The highermagnetic flux density may treat the higher number of muscle fiberscontraction and the more adipose tissue may be reduced. Therefore thevisual appearance of regions prone to cellulite may be enhanced.

Treatment by time-varying magnetic field may induce lipolysis. Adiposetissue may be reduced by decreasing the number and/or volume of adiposecells. Promoted adipose cell metabolism may increase as the value ofmagnetic flux density increases. The treatment may release free fattyacids (FFA) from at least one adipose cell. The increased concentrationof FFA may influence a homeostasis of the adipose cell. A disruption ofthe homeostasis may cause a dysfunction of the adipose cell. Thedysfunction may be followed by stress for endoplasmic reticulum (ERstress). ER stress may cause additional lipolysis and/or apoptosis ofthe at least one adipose cell.

Furthermore, ER stress may cause increase of intracellular calcium ions(Ca2+) which may promote an apoptotic process and may continue intocontrolled cell death of the adipose cell. The apoptosis may be inducedby Ca− dependent effectors, e.g. calpain or caspase-12. Endogenousligands or pharmacological agents, such as vitamin D, may induceprolonged cytosolic calcium increase. Vitamin D may influence release ofCa2+ from endoplasmic reticulum. Hence the effect of treatment may beenhanced by application of vitamin D and/or Ca2+ prior, during and/orafter the treatment. The most significant effect may be achieved byapplication of both, Ca2+ and vitamin D, prior the treatment to provideall factors influencing adipose cell apoptosis.

Alternatively, increased level of Ca2+ may induce autophagy withinadipose cell as well. Autophagy is self-eating process of cellularorganelles to produce energy and it may proceed into cell death.Autophagy may be induced by ER stress or it may be induced via Ca2+signaling.

FIG. 14 illustrates pathways which may induce apoptosis of the at leastone adipose cell. FFA may accumulate in the at least one adipose cell(1401). The magnetic field may induce lipolysis (1402), i.e. a releaseof FFA from adipose tissue. Accumulated FFA may reach a threshold whenadipose cell is unable to utilize FFA. A dysfunction of the adipose cellmay occur. The adipose cell may react on the dysfunction by ER stress(1403). ER stress may induce lipolysis hence additional release of FFAmay occur (1401). ER stress may cause apoptosis of the adipose cell(1404). Furthermore, the ER stress may release Ca2+(1405) which maycontribute the apoptosis (1404).

The effect of the treatment by magnetic field for adipose tissuereduction may be influenced by various biological processes and/orpathways as recited above. The processes and/or pathways may be synergichence the adipose tissue reduction may be accelerated and/or moreefficient.

The method may cause the circumferential reduction i.e. a reduction ofthe size of the treated body region. The method may be mostly indicatedfor the regions with cellulite, particularly for thighs, buttocks,saddlebags, love handles, abdomen, hips and/or arms. However, theindication is not limited to the mentioned regions and the method may beused for treatment of any other body region.

Furthermore, the method may change BMI index of the patient. In apreferred application the BMI of the patient may be reduced.Alternatively, the BMI of the patient may increase.

Heating/Cooling

The magnetic field may be combined with application of heat and/or cold.The body region may be heated/cooled. The target biological structuresmay be selectively treated due to different tolerance of variousbiological structures to heating/cooling. Applying of heat/cold mayimprove metabolism of the biological structure, alternatively areduction of the biological structure may occur.

Various biological structures have a different tolerance toheating/cooling. Hence target biological structures may be remodeled,e.g. adipose cells may be selectively reduced. The cells different fromadipose cells such as epidermal cells, are not reduced by theheating/cooling. The selective reduction of adipose cell may be causedby e.g. crystallization within adipose cells. The heating/cooling of theadipose cell may reduce the number and/or volume of adipose cells bylipolysis, apoptosis and/or necrosis.

Cooling

Although the following exemplary treatment describes applying cold tothe patient, the treatment method is not limited to the exemplaryapplication. The method may include heating the patient instead ofcooling the patient.

The cooling may be provided in a contact, indirect contact and/ornon-contact manner. Contact cooling may be provided by a cooling elementplaced to the proximity of the treated body region, e.g. a thermallyconductive material such as metal, gel or ice may be used. Indirectcontact may be provided by a flow of cooling media within a layer offlexible and/or rigid material, e.g. cooling media such as glycerol,saline or water solution may be used. The cooling element may include aplurality of passages which the cooling media may flow in. Non-contactcooling may be provided by radiant cooling. Alternatively cooling mediamay be applied directly on the body region. The cooling media used fornon-contact heating/cooling may be preferably a fluid, e.g. a gas orliquid. The gas may be applied in form of a spray, e.g. cold air, CO₂ orN₂ may be used. The cooling media may be at a predetermined temperaturewhich may be controlled by the device to induce selective treatment ofthe target biological structure.

In an exemplary application the adipose cells may be selectively treatedby cooling. A cooling media may be applied to the body region. Areduction of adipose cell may be induced by cooling the adipose cell.The cells different from adipose cells are not reduced by the cooling.

Temperature Ranges

The temperature of the cooling media and/or element may be less than thetemperature of the patient's body. The temperature of cooling media maybe at least −196° C. The temperature of the cooling element may bepreferably in the range of 40 to −40° C., more preferably in the rangeof 20 to −20° C., even more preferably in the range of 10 to −15° C. orin the range of 5 to −10° C. A temperature of the adipose cells may beabove a freezing point of water to prevent a reduction of cellsincluding water. The temperature of the adipose cells may be preferablyin the range of 37 to −10° C., more preferably in the range of 20 to −4°C., even more preferably in the range of 15 to −2° C. or around 4° C.The temperature of epidermis may be at least −40, −20, −10, 15, 20, 35°C., more preferably the temperature of epidermis may be in the range ofaround 5 to −5° C. The term around may be interpreted to mean in therange of 10% of the particular value.

Alternatively the body may be heated by application of various treatmentmethods, e.g. radiofrequency, diathermy or optical waves. Thetemperature in the target tissue may be up to 80° C., more preferably inthe range of 37 to 60° C., even more preferably in the range of 39 to50° C., most preferably in the range of 42 to 47° C. The temperature maybe adjusted based on the intended use, e.g. adipose tissue reduction orcollagen production.

The temperature of adipose cells may vary during the treatment. Thetemperature of the adipose cells may oscillate around a predeterminedtemperature. The temperature of the adipose cells may also follow atemperature profile in a predefined temperature range. The temperatureand/or the temperature range may be adjusted following the patient'sneeds.

Cycles

Alternatively the adipose cells may be heated prior, during and/or aftercooling. The term “heat prior” refers to preheating the adipose cellsbefore cooling treatment. The term “heat during” refers to cyclicallychanging periods of cooling and heating the adipose cells during thetreatment. The treatment may also include passive periods betweenheating and/or cooling. The term “passive period” refers to applyingneither heating nor cooling. The term “heat after” refers to applyingheat after the cooling treatment. The periods of heating/cooling and/orpassive periods may be adjusted following by the patient's need.

Treatment Duration

The cooling may be applied for at least 10 seconds. Time duration ofcooling the body region may be in the range of 1 to 240 minutes, morepreferably in the range of 5 to 120 minutes, even more preferably 10 to60 minutes, most preferably up to 30 minutes.

The cooling element and/or media may be applied continuously and/or inpulses. Continuous application may be used for a cooling element and/ormedia at a temperature above 0° C. Pulsed mode may be used forapplication of fluids below 0° C. The cooling may be provided cyclicallyfor short periods in order of milliseconds, e.g. N₂ may be appliedcyclically to prevent damage to epidermis/dermis. The cooling elementand/or media may be applied preferably non-invasively, e.g. by topicalapplication. Alternatively the cooling element and/or media may beapplied subcutaneously, e.g. injected.

Adjustable Applicator

The cooling element may correspond with the body region. The coolingelement may be adjustable in shape to fit the body region. The coolingelement may be made of flexible material to be modified in shape tofollow the shape and/or contour of the body region. A fitting of thecooling element may provide homogenous treatment and/or temperaturedistribution. Further the heat exchange may be optimized at thecontacted surface.

Pressure

A treatment may induce a thermal gradient in the body region, i.e. theshallow layer of the skin such as epidermis and/or dermis may have alower temperature than the deeper layer such as adipose tissue. Theeffect of cooling may be improved by limiting and/or eliminating dermalblood flow. The dermal blood flow may be limited by applyingvasoconstrictive medicine, preferably topically administered.

Positive

The dermal blood flow may also be limited and/or eliminated by applyinga pressure. The pressure greater than systolic blood pressure may beused for pushing the blood out of the dermal and/or subcutaneous veins.The deeper adipose cells may be cooled and/or the cooling of the adiposecells to the temperature sufficient to reducing the adipose cells may bereached in shorter time period. Furthermore appropriate contact of thecooling element may be provided by the pressure in case of contacttreatment.

Negative

The treatment effect may also be enhanced by applying negative pressureto the skin below the applicator, e.g. a convex cooling element may beused. The skin may be pulled towards the inner surface of the coolingelement. Hence the contact may be enabled by applying negative pressure.Alternatively, the folded tissue may be pinched by two or more coolingelements and the cooling may be applied to the tissue, particularly toadipose cells. Further the skin may be stretched and a thickness of theskin may decrease. Skin thickness decrease may promote improved heattransfer to/from adipose cells.

Miscellaneous

The cooling may be applied with application mechanical treatment such asacoustic, ultrasound, and/or shockwave treatment to enable morehomogenous treatment effect. The adipose cells reduction may also bepromoted by physical movement of the body region by e.g. massaging, orvibrations. The pressure applied to the body region may vary to improvethe results.

Protocols

An apoptotic index may increase after cooling the body region. Theapoptotic index refers to a percentage of apoptotic cells in specimen.The apoptotic index may increase due to cooling up to ten times greatervalue compared with the value prior the cooling.

Based on the apoptotic index a treatment combining various methods maybe designed as a tailor-made solution following the patient's need. Thecooling may be applied to the body region of the patient prior, duringand/or after applying a magnetic field to the patient.

Pain Relief

A pain relieving medicament may be provided during the treatment if thepatient is more sensitive to decreased temperature. A topicalapplication may be preferred. The pain relief effect may be provided bya magnetic field of repetition rate at least 100 Hz, more preferably 120Hz, even more preferably at least 140 Hz or at least 180 Hz. The painrelieving effect may be provided before, during or after the treatment.

Precooling

Cooling the body region prior to applying the magnetic field mayinfluence a metabolism of adipose cells. Alternatively, the cooling ofthe adipose cells may induce apoptosis, lipolysis, autophagy and/ordisruption of the adipose cells. A release of FFA from adipose cells mayinduce ER stress as recited above. The application of the magnetic fieldmay cause at least partial muscle contraction reducing the adiposecells. Furthermore the released FFA from adipose cells influenced bycooling may be used as energy source for muscle work. Hence the coolingmay be followed by treating a patient by magnetic field inducing atleast partial muscle contraction. Due to the combined effect of coolingand magnetic treatment the adipose cells may be reduced in number and/orvolume. Moreover the muscles may be shaped, tightened, strengthenedand/or the volume of the muscle may increase. Additionally, thecellulite appearance may be reduced due to muscle work.

The magnetic treatment may provide a massage effect. Hence blood and/orlymph flow may be improved. Additionally frozen tissue may be relaxed.

The combined magnetic treatment may be applied immediately aftercooling, more preferably around 1 to 24 hours after cooling, e.g. 1, 2,8 or 20 hours after cooling. The combined treatment may be appliedperiodically. Alternatively, the treatment by cooling and/or magneticfield may be applied separately, e.g. treatments may alternate inappropriate periods. The period may last from 12 hours to 1 month, morepreferably from 1 day to 2 weeks, most preferably from 3 days to 1 week.

In an exemplary application of the treatment method a patient's bodyregion may be cooled by a cooling element for e.g. at least 20 minutesup to 1 hour. After stopping the cooling the body region may be treatedby magnetic field for e.g. 15 to 45 minutes.

Cooling

Cooling the body region may be applied simultaneously while the bodyregion is treated by magnetic field within one treatment.

The magnetic cooling may be provided to the patient while the patient isbeing treated by magnetic field.

Alternatively, cooling may alternate with treatment by magnetic field,i.e. the magnetic field is applied when cooling is not provided to thepatient or vice versa. Periods of alternating cooling and magnetictreatment may vary.

The magnetic field may be preferably applied in burst mode. Each burstcontains train of magnetic impulses and a period of no magnetictreatment. The train may include a plurality of magnetic impulses. Anumber of magnetic impulses may vary in the range of at least 1 to 10000impulses, more preferably in the range of at least 10 to 1000 impulses.The time duration of the train and/or the period of no magnetictreatment may vary in order of milliseconds to order of seconds, e.g. inthe range of 100 milliseconds to 100 seconds, more preferably in therange of 1 to 30 seconds, most preferably in the range of 5 to 15seconds.

An essential principle of magnet therapy used for biological structurestimulation is the influence of the magnetic field on the cell. The cellmembrane is polarized due to the induced electric current. One offundamental phenomenon of electric current in biological tissue may bean action potential occurrence, a transfer of neural excitation and/or apartial or full muscle contraction may be induced. Additionally, theeffect of the generated action potential may modulate a painful stimulustransmission, providing a pain management effect.

According to still another application of the invention, the neuralstructure stimulation by time-varying magnetic field may be used forpain management.

According to one approach of the aspect of the application in painmanagement, the neural structure may be stimulated by an envelopecreated by higher repetition values e.g. exceeding 100 Hz, morepreferably at least 150 Hz, even more preferably at least 200 Hz, mostpreferably at least 250 Hz, or up to 700 Hz. The envelope may begenerated with predefined repetition frequency and/or shape.

According to still another approach of the aspect of the application inpain management, the neural structure may be stimulated by trains 1501of several pulses 1502 and time with no stimulation after the train1501. The group of several pulses 1502 and the time with no stimulationis called burst 1504. Therefore one burst 1504 consists of the only onetrain 1501 and time with no stimulation 1503. The train 1501 preferablyconsists of at least 2 pulses, more preferably 5 pulses, even morepreferably tens pulses or up to hundreds pulses; repetition rate of thepulses 1502 is at least 100 Hz. The burst repetition rate may varyfollowing the patient's needs. In the preferred application the burstrepetition rate vary from 1 to 10 Hz. The number of pulses 1502 in train1501 and/or the time with no stimulation may vary following the patientneeds.

FIG. 15 shows an example of application of the stimulation bytime-varying magnetic field with a repetition rate of 125 Hz in clusters1501 consisting of 5 pulses 1502, with a burst 1504 repetition rate 10Hz. Total time duration of one burst 20 is 100 ms. Total stimulationtime of one cluster 1501 is 40 ms, hence the time with no stimulation1503 is 60 ms. The most important advantage of this approach isanalgesic effect and almost no adaptation of the neural structure to thestimulation. The approach may be used e.g. for alleviating the acutepain.

In an alternative application the neural structure may be stimulated byrectangular or increasing shaped envelope as well.

According to another aspect of the application in neural systemdiagnostics, the neural structure may be stimulated by single pulses orrectangular shaped envelope, and by increasing shaped envelope. Bothenvelopes are used for determination of minimal magnetic flux densityvalue sufficient to induce at least partial muscle contraction. Theenvelope duration may last 1 second. After the determination of bothmagnetic flux densities values, the level of muscle denervation may becalculated.

According to still another aspect of the invention, the magnetictreatment may be used for treatment of diabetes, e.g. function ofpancreas and/or liver may be improved. The magnetic field may influencehyperglycemia. Hence the treatment may reduce diabetic neuropathy whichis caused by hyperglycemia.

Furthermore, the magnetic treatment may relieve the consequences of theneuropathy by locally improved blood, perfusion, metabolism or lymphcirculation. The progress of the neuropathy may be inhibited, e.g. footinfection may be treated and/or reduced hence amputation may beprevented. Moreover, the magnetic treatment may be used for inducingpain relieving effect. The diabetes may be associated with venous ulcerswhich may be treated by magnetic treatment as well. The treatment ofvenous ulcer may be treated by similar effects as the consequences ofthe neuropathy.

In one exemplary application the body region may be cooled for a periodof e.g. at least 5 minutes. After stopping the cooling the body regionmay be treated by a magnetic field for a period of e.g. at least 5minutes. After stopping the magnetic treatment the body region may becooled.

Post Cooling

The cooling may also be applied after magnetic treatment. The treatmentby magnetic field may provide stimulation, pain relief and/or amyorelaxation effect for the treated body area before cooling. Thecooling applied with pressure may be better accepted by the adiposetissue when the muscle below the adipose cells is relaxed. Alternativelythe magnetic treatment may provide a temporary pain relief effect hencea patient suffering from a lower pain threshold, e.g. cool sensitivity,may be treated.

In an exemplary application the body region may be treated by a magneticfield for a period of e.g. at least 15, 20 or 30 minutes. After stoppingthe magnetic treatment the body region may be cooled.

The cooling may be applied immediately after magnetic treatment, morepreferably around 1 to 24 hours after magnetic treatment, e.g. 1, 2, 8or 20 hours after magnetic treatment. The combined treatment may beapplied periodically.

In an exemplary application of the treatment method a patient's bodyregion may be treated by magnetic field for e.g. at least 20 minutes upto 1 hour. After stopping the magnetic treatment the body region may betreated by cooling for e.g. 15 to 45 minutes.

In the previously described exemplary treatment methods the cooling ofthe patient may be replaced by heating the patient.

FIGS. 16A and 16B illustrate an application of the treatment by a deviceproviding heating/cooling to the body region of the patient 1601. FIG.16A illustrates a treatment device 1602 including a connection to powersource, a magnetic field generating device 1603 and means for providingheating/cooling 1604, e.g. RF source or cooling element. FIG. 16Billustrates alternative treatment applied by two separate treatmentdevices, i.e. by a device providing magnetic treatment 1605 and a deviceproviding heating/cooling 1606.

All the recited combined treatment methods may be provided by at leastone applicator. The applicator may provide cooling and magnetictreatment. Alternatively one applicator may provide cooling and secondapplicator may provide magnetic treatment.

Combined Magnetic and Radiofrequency

The target structure may be treated by combined methods which may beused for remodeling the adipose tissue, body shaping and/or contouring,muscle toning, skin tightening, skin rejuvenation, wrinkle removing,reducing stretchmarks, breast lifting, lip enhancement or treatment ofcellulite in general by application of electromagnetic radiation totarget structure to selectively heat the target tissue to remove and/orremodel adipose tissue from the target tissue. The second approach is totransmit a magnetic treatment to the target structure, inducing at leastpartial muscle contraction within the target structure to remodel theadipose tissue by natural adipose tissue catabolism. Adipose tissuecatabolism may be caused by apoptosis or necrosis of the adipocytes. Themuscle contraction caused by induced eddy current is the same as anatural contraction. The adipose tissue may be reduced in natural way.Additionally, the muscle may be shredded in a natural way. Therefore theeffect resulting in body shaping and/or contouring may be significantlyimproved.

The combination of the recited method may improve currently usedapplications in various aspects and the effect of the treatments may besignificantly enhanced. The application of a radiofrequencyelectromagnetic field may be combined with application of a magneticfield applied before, simultaneously or after the radiofrequencytreatment. The application of a magnetic field may induce many benefitsfor radiofrequency treatment, such as applications inducing at leastpartial muscle contraction, myorelaxation effect or analgesic effect.The perfusion or metabolism may be improved as well.

The at least partial muscle contraction may induce enhanced effects onadipose tissue reduction by catabolism of the adipose tissue and burningenergy from adipose tissue. The total adipose tissue reduction effectmay be enhanced by radiofrequency treatment.

Additionally, the at least partial muscle contraction may improve ablood flow and/or perfusion in the treated body region. The improvedblood flow may be caused by activation of muscle pump and/or by themuscle necessity of more oxygen due to the at least partial contraction.The blood flow may increase rapidly and it may last temporarily,preferably up to 1 hour, more preferably up to 45 minutes, mostpreferably up to 30 minutes. Due to increased blood flow and/or localperfusion, the risk of overheated muscle may be limited or eveneliminated. Further the homogeneity of the thermal field induced bythermal effect of radiofrequency treatment may be significantly enhancedand/or the temperatures may be well-balanced/compensated in the targetbody region. Still another benefit may be prevention of creation any hotspot caused by steep thermal gradient.

Due to improved blood flow, perfusion and/or lymph flow the metabolismmay be improved. Additionally, the effect of radiofrequency treatmentmay be enhanced by improved metabolism, e.g. cellulite treatment, bodyshaping and/or contouring, skin tightening or skin rejuvenation. Furtherbenefit may be reducing or eliminating the risk of panniculitis or localskin inflammation since any clustering of the treated adipocytes may beprevented by the improved metabolism. The improved blood and/or lymphflow may contribute the removing of the adipocytes. The removing of theadipocytes may be promoted by higher number of cells phagocytosing theadipocytes as well. Synergic effects of magnetic and RF treatment maysignificantly improve metabolism. Therefore the possibility of adverseevent occurrence may be limited and treatment results induced by thepresent invention may be reached in shorter time period.

Further the at least partial muscle contraction may improve the movementof lymphatic vessel and the lymph flow may be improved.

In the preferred application the RF and/or magnetic field may bemodulated. In the most preferred application both treatments aremodulated. The magnetic treatment may be modulated in the magnetic fluxdensity domain, repetition rate domain, or impulse duration domain, toprovide different treatment effects and to prevent adaptation of thetarget biological structure. The radiofrequency treatment may bemodulated in the frequency domain, intensity domain and/or time domainto reach the most complexity and/or efficiency of the target treatedbiological structure. The modulation in the time domain may be changingthe active and passive periods of stimulation, e.g. the radiofrequencytreatment may include period with no stimulation, i.e. theradiofrequency treatment may be not continual but the treatment may beprovided in pulses. The periods of no stimulation may vary and may beadjusted by the operator. Due to modulation during the treatment,different target biological structures may be treated in the differentdepth.

The application may be contact or in the preferred application thetreatment may be applied contactless. Contactless application may avoidall biocompatibility factors which may occur during contact treatment.In the most preferred application the treatment may be provided byself-operated device. Hence the applicator and/or magnetic fieldgenerating device need not be guided by the operator. The applicator maybe fixed at a sufficient distance from the patient's skin enabling safetreatment for the patient. Self-operated treatment may be provided by ahand-held applicator or the applicator may be fixed to stand-alonedevice. The self-operated treatment may be also enabled using varioustypes of sensors in communication with the device for monitoring thetreatment and/or the patient. The at least one sensor may be e.g.reactive sensor, electrochemical sensor, biosensor, biochemical sensor,temperature sensor, sorption sensor, pH sensor, voltage sensor, sensorfor measuring distance of applicator from the patient surface and/orfrom the treated area, position sensor, motion detector, photo sensor,camera, sound detector, current sensor, sensor for measuring of specifichuman/animal tissue and/or any suitable sensors measuring biologicalparameters and/or combination thereof such as sensor for measuringdermal tensile forces, sensor for measuring the activity of the muscle,muscle contraction forces, tissue impedance or skin elasticity.

Further the homogeneity of the treatment may be improved by severalapproaches. A first approach may be represented by a moveable applicatorproviding the dynamic treatment to a large target area. The dynamictreatment may improve the homogeneity of applied treatment energy andadditionally due to large area the effect is uniform and/or wellbalanced. Static positioning of the applicator may be used as well.Another approach of improving homogeneity may be represented by using abolus. The bolus may provide improved transmittance of theelectromagnetic energy to the treated biological structures.Additionally, the bolus may prevent occurrence of hot spots within thetreated area; the bolus may provide constant temperature to the targettreated surface area; or the bolus may increase the homogeneity of theradiofrequency waves application by providing a homogenous medium forelectromagnetic waves propagation not being influenced by the interfaceof the target treated area and an air. The bolus may profile theelectromagnetic field to enhance the effect of the treatment. In stillanother approach an air gap may be between the applicator and thepatient.

The treatment by magnetic and/or electromagnetic field may be incontinuous or discrete mode. In one application the magnetic treatmentmay be applied in continual mode with no pauses and the electromagnetictreatment may be applied in pulsed mode to provide improved adiposetissue reduction caused by natural process and by the increasedtemperature. In another application the electromagnetic treatment may beapplied continuously with no pauses and the magnetic treatment may beapplied in pulsed mode to provide improved thermal reduction of adiposetissue and by improved metabolism due to improved blood flow. Both modesmay be combined in various treatment sequences.

In the preferred application the treatment may be started at the momentwhen the target biological structure reaches the predeterminedtemperature. The temperature in the target tissue may be up to 80° C.,more preferably in the range of 37 to 60° C., even more preferably inthe range of 40 to 45° C. The temperature may be adjusted based on theintended use, e.g. adipose tissue reduction, collagen production ormuscle contraction. In an alternative application the intended use maybe coagulation and/or ablation. The temperature in the target biologicalstructure may be measured by invasive method, e.g. using an invasiveprobe; or by contact method, e.g. using thermocouple sensor; or bycontactless method, e.g. using infrared sensor or camera. Thetemperature of the target biological structure may be determined by amathematic method. The sensor for measuring the temperature in thetarget biological structure may be attached to the applicator.

The applicator may include at least one sensor for detecting thetemperature of the skin. The sensor may be preferably contactless.Alternatively the sensor may measure the temperature in contact manner.Alternatively, the skin impedance may be determined as well.

A benefit of the application of magnetic treatment and electromagnetictreatment may be causing an analgesic effect of the application andproviding a possibility of treating a patient with higher sensitivityfor thermal effects induced by electromagnetic treatment, i.e. patientswith any predisposition inducing increased thermal sensitivity. Theanalgesic effect may be induced by magnetic treatment by suitablerepetition rates and it may be induced immediately during the magnetictreatment. The analgesic effect may last up to several hours aftermagnetic treatment. The magnetic flux density of the magnetic treatmentmay preferably reach at least motor-threshold intensity inducing atleast partial muscle contraction therefore the homogeneity of thethermal field may be significantly enhanced.

Another benefit of application the magnetic treatment may be causing amyorelaxation effect. The magnetic treatment may be applied on spasticmuscle structures to relieve the hypertonus of the muscle and improvingthe blood and/or lymph flow. Therefore relieving the hypertoned musclemay contribute to the analgesic effect and contribute to theacceptability of the treatment by the patient.

The blood and/or lymph flow may be limited in the spastic muscles andthe metabolism may be limited as well, meaning that the risk ofclustering the treated target structures may be higher and possibleadverse events may occur. The recited risks may be eliminated by theused of magnetic treatment.

In one aspect of the invention, the treatment by magnetic field may beapplied to the target structure before the radiofrequency treatment toprepare the target structure for following treatment by radiofrequencyfield. The effect of magnetic treatment may be to induce at leastpartial muscle contraction or to treat a muscle structure to increase amuscular tonus of the target structure. Both effects may provide amassage effect for the structure within the proximity of the targetstructure hence the blood and/or lymph circulation may be improved topromote local metabolism. The temperature may be locally increased bythe improved blood flow and the target structure may accept thefollowing radiofrequency treatment at significantly higher quality.Additionally, the collagen and/or elastin fibers may be remodeled orrestored and/or its neogenesis may be improved to provide a younger,smoother, firmer and enhanced skin appearance.

Additionally, previous application may improve acceptability of theelectromagnetic field by increasing the temperature of the skin and thetransmittance of the electromagnetic field may be improved due to lessvalue of skin impedance. Further the radiofrequency may penetrate deepertarget structures relative to treatment without a preceding magnetictreatment of the target structure and/or area.

Another benefit may be releasing the adipose tissue in the muscle bymuscle contraction and/or by temperature increase causing betterliquidity of adipose tissue. Still another benefit of the at leastpartial muscle contraction may be mechanical breaking large adiposetissue bulks into smaller bulks which may be easier metabolized and/orthe smaller adipose tissue bulks may be removed faster by the lymphaticand/or blood flow. Due to improved metabolism and/or circulation thecellulite may be treated in a short time and the visual effect on skinappearance may be significantly enhanced.

In another aspect of the invention, the treatment by magnetic field maybe applied to the target structure simultaneously with theradiofrequency treatment to improve effects of the electromagnetictreatment inducing heat in the target structure.

The simultaneous application of magnetic treatment and radiofrequencytreatment may be in two modes: a first mode may generate the magneticimpulses while radiofrequency treatment is active or another mode maygenerate radiofrequency treatment while the magnetic treatment is not inan active stimulation period, i.e. the period of magnetic treatment andradiofrequency treatment alternates. Both modes amplify the resultingeffect of the treatment. Therefore the results may be achieved insignificantly shorter time than the same results achieved by separateapplications of the radio frequency and magnetic treatments.

The simultaneous method of magnetic treatment and radiofrequencytreatment of the target tissue may increase the peak magnetic componentof the entire treatment resulting in improved heating of the targetstructure including containing higher water volume, e.g. skin. Due toincreased temperature of skin, the production and/or remodeling ofcollagen and/or elastin fibers may be improved and the skin may beprovided with a younger, smoother, firmer and enhanced appearance. Theeffect of overheating the muscle may be reduced by the improved bloodflow.

In still another aspect of the invention, the treatment by magneticfield may be applied to the target structure after the treatment byelectromagnetic field to enhance and/or contribute to the effects ofradiofrequency treatment by influencing the target structure by magneticfield.

The magnetic field may treat the target structure to cause at leastpartial muscle contraction proximate to the target structure to improveblood flow and provide homogenous temperature distribution at highquality after creating a temperature distribution at lower quality byradiofrequency treatment.

All of the methods may be provided by the above recited technicalsolutions. The above mentioned methods may be used separately or in anycombination.

The method may cause the circumferential reduction i.e. a reduction ofthe size of the treated body region. The method may be mostly indicatedfor the regions with cellulite, especially for buttocks, saddlebags,love handles, abdomen, hips, thighs or arms. However, the indication isnot limited to the mentioned regions and the method may be used fortreatment of any other body region.

The at least one applicator may include at least one magnetic fieldgenerating device. The plurality of magnetic field generating devicesmay be positioned in isolated locations of the at least one applicator.Alternatively, the magnetic field generating devices may be positionednext to each other, in an array or matrix, in a pattern or in randomizedlocations of the at least applicator.

The magnetic field generating devices may be positioned and/or moved inthe at least one applicator in one plane; in at least two mutuallytilted planes defined by a convex or concave angle, or perpendicular toeach other; or in at least two parallel planes with the at least onemagnetic field generating device in each parallel plane. The movement ofthe at least one magnetic field generating device may be translationaland/or rotational, constant or accelerated. The movement may follow apredetermined, random or predefined trajectory, such as a pattern, arrayor matrix. The movement of the at least one applicator may be handled insimilar manner as the movement of the at least one magnetic fieldgenerating device. The angles of the planes and/or the movement of theat least one magnetic field generating device may be adjusted by anoperator following the patient's needs. The positioning may be providedby mechanical holder, enabling tilting, distancing and positioningmagnetic field generating device in various planes. In an alternativeembodiment the patient may be positioned in the intersection of themagnetic fields generated by the plurality of magnetic field generatingdevices. In the preferred application the at least one applicator may bemovable and the movement may be circular.

The plurality of magnetic field generating devices may be positionedwithin one applicator having form of mechanical holder. The shape of theapplicator having form of mechanical holder may be adjustable, e.g. theapplicator may include at least one moveable part. In a preferredembodiment the applicator having form of mechanical holder may providespatial arrangement of the energy delivery elements in one axis, twoaxes or three axes and/or provide tilting and/or rotation. Theapplicator having form of mechanical holder may provide fixation of theat least one magnetic field generating device in one position. Themoveable parts may be connected by sliding mechanism and/or by a jointmechanism. An exemplary embodiment of such an applicator may be found inU.S. Pat. No. 9,468,774, incorporated herein by reference. Theapplicator may be adjustable following the body region and/or biologicalstructure.

The static position of the at least one applicator may be provided by apositioning member. The positioning member may be e.g. an arm or anadjustable flexible belt. The positioning member may include a bucklefor adjusting the length of the belt. The applicator may be placedwithin predefined locations of the belt. Alternatively the applicatormay be shaped to be moveable along the positioning member, e.g. theshape of the applicator may be preferably concave, e.g. V-shaped orU-shaped. The positioning member may be inserted itself into theconcavity of the applicator. The position of the applicator may beadjusted by limited movement along the positioning member because thepositioning member may be used as guiding member. However, theapplicator may not be fixed to a particular static position. Theposition of the applicator may be dynamically adjusted during thetreatment following the patient's needs. The position of the applicatormay be adjusted manually by the operator, or automatically by thetreatment device. In one exemplary embodiment a plurality of applicatorsmay be used for treating larger body regions, e.g. buttocks, abdomen orthigh.

The present methods may also induce muscle contraction to reduce effectof skin laxity. Skin laxity may be caused by e.g. aging process orincreasing number and/or volume of adipose cells which pulls down theskin by gravity, rapid weight loss or skin stretching during thepregnancy. The muscles may be treated by the induced electric current tocontract. Repetitive contractions may cause the muscles to obtain thetonus and flexibility. Therefore the skin appearance may be enhanced bytreating the flabby muscles. The effect of skin tightening may beachieved. The method also may promote the collagen and elastin fibers inthe layers subtending the epidermis hence the skin may obtain enhancedvisual appearance. The method may be widely applied but not limited toapplication to the regions of neck, breasts, arms or abdomen. The methodmay provide the smoother and younger appearance of the skin to thepatient.

Similar methods of the muscle structure treatment by time-varyingmagnetic field for inducing the at least partial muscle contraction maybe used for treatment of wrinkles as well. Wrinkles are results ofextrinsic and intrinsic factors. Nowadays, wrinkles are considered to benegative effect of natural aging process which decreases the productionof collagen and elastin fibers and weakens the skin which becomesthinner. As the muscle treatment by the magnetic flux density may induceat least partial muscle contraction, the collagen and elastin fibersneogenesis may be improved. Additionally, the muscles subtending thetreated region may be toned and the skin may obtain a younger andenhanced visual appearance. Therefore, the effect of skin tightening maybe achieved.

Wrinkles may be prevented or reduced by practicing facial exerciseswhich may cause a massage effect to the facial tissues, improving bloodand lymph circulation. Additionally, the facial muscles may be relaxedand toned after the exercise. A similar effect as facial exercise may beachieved by non-invasive and/or contactless method of treating thefacial muscles by magnetic flux density. Further additional advantage ofthe present method may be the improvement of restoration of the collagenand elastin fibers, more effective toning and strengthening of thefacial muscles.

The present methods may improve the neogenesis and remodeling ofcollagen fibers in the lips to reach a full, plump and firmerappearance. The magnetic flux density may be applied to the lips by anapplicator. Therefore the lips may become fuller and firmer without anyneed of invasive method such as injection of the synthetic fillers,permanent makeup or the facial implants. The present method may promotethe remodeling and/or neogenesis of collagen fibers in a natural way.Additionally, the collagen is natural substance of the human body whichmay provide the elasticity to the structure.

The present methods may be used for enhancing the visual appearance ofbreasts. Cooper's ligament may be treated, improved and/or firmed by theat least partial muscle contraction. The treatment may induce theelevation of the breast tissue. Additionally, the breast tissue may betreated to be modified in a shape, wherein the shape includes the sizeand/or the contour of the breast tissue. Therefore the visual appearancemay be enhanced and breasts may be more attractive for the patient. Thepresent method may be a non-invasive alternative for current aestheticsurgery method for the treatment of sagging breast tissue. The presentmethod may provide a patient a method of breast visual appearanceenhancement without surgery. Therefore the method lacks post-surgerycomplications such as scars, postoperative pain or long recovery period.Various treatment protocols may be used.

Following the recited methods the treatment may be but is not limited tocontinuous, pulsed, randomized or burst. The impulse may be but notlimited to monophasic, polyphasic, biphasic and/or static magneticfield. In the preferred application the magnetic impulse may be inbiphasic regime, i.e. it is consisted of two phases, preferably positiveand negative.

In the preferred application of the present method the trains of pulses,called bursts are used.

Repetition rate and/or magnetic flux density may vary during thetreatment protocol. Further the treatment may include several periods ofdifferent repetition rates, therefore the modulation may be inrepetition rate domain. The treatment may include several periods ofdifferent magnetic flux densities, therefore the modulation may be inmagnetic flux density domain. Alternatively the treatment may includedifferent impulse durations, therefore the modulation may be in impulseduration domain. In yet another approach the treatment may be modulatedby any combinations thereof.

Various envelopes and/or waveforms, e.g. pulse, sinusoidal, rectangular,square, triangular, saw-tooth, trapezoidal, exponential etc. for thepurpose of muscle treatment may also be used, and are not limited torecited shapes.

The values of magnetic flux density and repetition rate are cited inseveral preferred applications since the perception of the treatment issubjective. Nevertheless, the magnetic flux density and repetition ratesare not limited by the recited values. A person skilled in the physicaltherapy is able to repeat and apply the treatment methods adjusting themagnetic flux density and/or repetition rate following the patient'ssensitivity or needs.

The present method is not limited to be used independently. Forenhancing the result the method may be used in combination with otherconventional non-invasive and/or invasive aesthetic treatment method.

All the recited methods may be applied to a patient in a non-invasiveand/or contactless way. Therefore the present methods provide aneffective alternative approach of enhancing the visual appearance withno need of invasive treatment or surgery. Further, the visual resultsare appreciable after several treatments. Additionally, the resultsinclude not only the visual appearance enhancement but even theimprovement of the muscle structures, hence the patient feels firmer andtighter. The muscle structures become toned with no need of any diet orspending time by exercising in fitness.

The patient may feel firmer and/or tighter. The skin may be alsotighter. Additionally, adipose tissue reduction may occur. Furthermore,cellulite may be reduced as well.

A method of treating a biological structure uses a combination ofnon-invasive methods for enhancing human appearance. The inventionutilizes electromagnetic radiation. Methods may be used for targetedremodeling adipose tissue, focused treatment of cellulite, bodycontouring, skin tightening or skin rejuvenation. The invention relatesto focused heating of the target tissue by electromagnetic waves,whereas the effect of focused heating of the target tissue is amplifiedby the effect of a pulsed magnetic field treatment.

The present invention discloses the advanced approaches in aestheticapplications, e.g. for cellulite treatment and/or body shaping. Combinedmethods of treatment by electromagnetic field and treatment by magneticfield are used. The electromagnetic field may include treatment byradiofrequency, infrared or optical waves. The magnet treatment may beprovided by permanent magnets, electromagnetic devices generating astatic magnetic field or time-varying magnetic devices. In the preferredapplication the treatment by a pulsed magnetic field and radiofrequencytreatment may be combined. However the application is not limited by therecited combination so the combined method may include magnet treatmentand any treatment by electromagnetic field, e.g. light treatment, IRtreatment or treatment by radiofrequency waves, e.g. microwaves, shortwaves or long waves.

Magnet treatment in combination with radiofrequency treatment may berepresented by two independent treatment devices, e.g. one treating thetarget structure by radiofrequency waves and the second treating thetarget structure by magnetic field. Both devices may have a separateapplicator for treating the target structure, or one applicator may beused by at least two devices, i.e. the applicator may be modular for aplurality of devices.

The aesthetic treatment device may include at least one HF frequencygenerator for providing energy for radiofrequency treatment and forproviding energy for magnet treatment. In an alternative embodiment, thedevice may include at least one HF frequency generator for providingenergy for radiofrequency treatment and at least one other independentfrequency generator for providing energy for magnet treatment. Thedevice may include plurality of applicators for providing separateradiofrequency or magnet treatments to the patient.

In alternative embodiment the applicator may provide a combination ofradiofrequency and magnet treatment. In one embodiment, the applicatormay include at least one radiofrequency electrode for providingradiofrequency treatment and at least one coil for providing magnettreatment. In another embodiment, the applicator may include at leastone electrode for providing radiofrequency treatment and at least onecoil providing magnet treatment, wherein the at least one RF sourceprovides energy for both at least one electrode and at least one coil.

In still another embodiment the at least one RF source may provide theenergy for the at least one coil providing magnet treatment wherein theat least one coil may be used as the at least one electrode. The essenceis the far different stimulation frequencies which are used for RFtreatment and magnet treatment. The coil in the high frequency field issimilar to the electrode. This enables the coil to be the electrode forradiofrequency treatment. In the preferred embodiment a flat coil may beused as the electrode.

The frequencies for the radiofrequency treatment may be in the range ofones of MHz to hundreds of GHz, more preferably in the range of 13 MHzto 3 GHz, most preferably around 13.56 or 40.68 or 27.12 MHz or 2.45GHz. The term “around” should be interpreted as in the range of 5% ofthe recited value.

The combination of the recited method may improve currently usedapplications in various aspects and the effect of the treatments may besignificantly enhanced. The application of a radiofrequencyelectromagnetic field is combined with application of a magnetic fieldapplied before, simultaneously or after the radiofrequency treatment.The magnetic field may be generated by a permanent magnet orelectromagnet. The magnetic field may be constant in time or in thepreferred application the magnetic field may be time-varying, morepreferably a pulsed magnetic field may be used. The application of amagnetic field induces many benefits for radiofrequency treatment, suchas applications inducing at least partial muscle contraction,myorelaxation effect or analgesic effect. The perfusion or metabolismmay be improved as well.

The at least partial muscle contraction may induce enhanced effects onadipose tissue reduction by catabolism of the adipose tissue and burningenergy from adipose tissue. The total adipose tissue reduction effect isenhanced by radiofrequency treatment.

Additionally, the at least partial muscle contraction may improve ablood flow and/or perfusion in the treated area. The improved blood flowmay be caused by activation of muscle pump and/or by the musclenecessity of more oxygen due to the at least partial contraction. Due toincreased blood flow and/or local perfusion, the risk of overheatedmuscle is limited or even eliminated. Further the homogeneity of thethermal field induced by thermal effect of radiofrequency treatment maybe significantly enhanced and/or the temperatures may bewell-balanced/compensated in the target treatment area. Still anotherbenefit is prevention of creation any hot spot caused by steep thermalgradient.

Further the at least partial muscle contraction may improve the movementof lymphatic vessel and the lymph flow may be improved.

Due to improved blood flow, perfusion and/or lymph flow the metabolismmay be improved. Additionally, the effect of radiofrequency treatmentmay be enhanced by improved metabolism, e.g. cellulite treatment, bodyshaping and/or contouring, skin tightening or skin rejuvenation. Furtherbenefit may be reducing or eliminating the risk of panniculitis or localskin inflammation since any clustering of the treated adipocytes may beprevented by the improved metabolism. The improved blood and/or lymphflow may contribute the removing of the adipocytes. The removing of theadipocytes may be promoted by higher number of cells phagocytosing theadipocytes as well. Synergic effects of magnet and RF treatmentsignificantly improves metabolism. Therefore the possibility of adverseevent occurrence is limited and treatment results induced by the presentinvention are reached in shorter time period.

In the preferred application the RF and/or magnetic field may bemodulated. In the most preferred application both stimulation signalsare modulated. The magnetic stimulation may be modulated in the magneticflux density domain, repetition rate domain, or impulse duration domain,to provide different treatment effects and to prevent adaptation of thetarget biological structure. The radiofrequency treatment may bemodulated in the frequency domain, intensity domain and/or time domainto reach the most complexity and/or efficiency of the target treatedbiological structure. The modulation in the time domain may be changingthe active and passive periods of stimulation, e.g. the radiofrequencytreatment may include period with no stimulation, i.e. theradiofrequency treatment is not continual but the treatment is providedin pulses. The periods of no stimulation may vary and may be adjusted bythe operator. Due to modulation during the treatment, different targetbiological structures may be treated in the different depth.

The application may be contact or the preferred application of theinvention the treatment may be applied contactless. Contactlessapplication may avoid all biocompatibility factors which may occurduring contact treatment. In the most preferred application thetreatment may be provided by self-operated device. Hence the continualsurveillance and/or control by the operator is not essential for correctand/or safe operation of the treatment device. Self-operated treatmentmay be provided by a hand-held applicator or the applicator may be fixedto stand-alone device. The self-operated treatment may be also enabledusing various types of sensors in communication with the device formonitoring the treatment and/or the patient. The at least one sensor maybe e.g. reactive sensor, electrochemical sensor, biosensor, biochemicalsensor, temperature sensor, sorption sensor, pH sensor, voltage sensor,sensor for measuring distance of applicator from the patient surfaceand/or from the treated area, position sensor, motion detector, photosensor, camera, sound detector, current sensor, sensor for measuring ofspecific human/animal tissue and/or any suitable sensors measuringbiological parameters and/or combination thereof such as sensor formeasuring dermal tensile forces, sensor for measuring the activity ofthe muscle, muscle contraction forces, tissue impedance or skinelasticity.

Further the homogeneity of the treatment may be improved by severalapproaches. A first approach may be represented by a moveable applicatorproviding the dynamic treatment to a larger target area. The dynamictreatment improves the homogeneity of applied treatment energy andadditionally due to larger area the effect is uniform and/or wellbalanced. Static positioning of the applicator may be used as well.Another approach of improving homogeneity may be represented by using abolus. The bolus may provide improved transmittance of theelectromagnetic energy to the treated biological structures.Additionally, the bolus may prevent occurrence of hot spots within thetreated area; the bolus may provide constant temperature to the targettreated surface area; or the bolus may increase the homogeneity of theradiofrequency waves application by providing a homogenous medium forelectromagnetic waves propagation not being influenced by the interfaceof the target treated area and an air. The bolus may profile theelectromagnetic field to enhance the effect of the treatment. In stillanother approach an air gap may be between the applicator and thepatient.

The treatment by magnetic and/or electromagnetic field may be incontinuous or discrete modes. In one application the magnetic treatmentmay be applied in continual mode with no pauses and the electromagnetictreatment may be applied in pulsed mode to provide improved adiposetissue reduction caused by natural process and by the increasedtemperature. In another application the electromagnetic treatment may beapplied continuously with no pauses and the magnetic treatment may beapplied in pulsed mode to provide improved thermal reduction of adiposetissue and by improved metabolism due to improved blood flow. Both modesmay be combined in various treatment sequences.

In the preferred application the treatment is started at the moment whenthe target biological structure reaches the predetermined temperature.The temperature in the target tissue may be up to 80° C., morepreferably in the range of 37 to 60° C., even more preferably in therange of 40 to 45° C. The temperature may be adjusted based on theintended use, e.g. adipose tissue reduction, collagen production ormuscle contraction. In an alternative application the intended use maybe coagulation and/or ablation. The temperature in the target biologicalstructure may be measured by invasive method, e.g. using an invasiveprobe; or by contact method, e.g. using thermocouple sensor; or bycontactless method, e.g. using infrared sensor or camera. Thetemperature of the target biological structure may be determined by amathematic method. The sensor for measuring the temperature in thetarget biological structure may be attached to the applicator.

A benefit of the application of magnet treatment and electromagnetictreatment may be causing an analgesic effect of the application andproviding a possibility of treating a patient with higher sensitivityfor thermal effects induced by electromagnetic treatment, i.e. patientswith any predisposition inducing increased thermal sensitivity. Theanalgesic effect may be induced by magnet treatment by suitablerepetition rates and it may be induced immediately during the magnettreatment. The analgesic effect may last up to several hours aftermagnet treatment. The magnetic flux density of the magnetic stimulationmay preferably reach at least motor-threshold intensity inducing atleast partial muscle contraction therefore the homogeneity of thethermal field is significantly enhanced.

In one aspect of the invention, the treatment by magnetic field may beapplied to the target structure before the radiofrequency treatment toprepare the target structure for following treatment by radiofrequencyfield. The effect of magnet treatment is to induce at least partialmuscle contraction or to stimulate a muscle structure to increase amuscular tonus of the target structure. Both effects may provide amassage effect for the structure within the proximity of the targetstructure hence the blood and/or lymph circulation may be improved topromote local metabolism. The temperature may be locally increased bythe improved blood flow and the target structure may accept thefollowing radiofrequency treatment at significantly higher quality.Additionally, the collagen and/or elastin fibers may be remodeled orrestored and/or its neogenesis may be improved to provide a younger,smoother and enhanced skin appearance.

Additionally, previous application may improve acceptability of theelectromagnetic field by increasing the temperature of the skin and thetransmittance of the electromagnetic field may be improved due to lessvalue of skin impedance. Further the radiofrequency may penetrate deepertarget structures relative to treatment without a preceding magnettreatment of the target structure and/or area.

Another benefit may be releasing the adipose tissue in the muscle bymuscle contraction and/or by temperature increase causing betterliquidity of adipose tissue. Still another benefit of the at leastpartial muscle contraction may be mechanical breaking large adiposetissue bulks into smaller bulks which may be easier metabolism of theadipose tissue and/or the smaller adipose tissue bulks may be removedfaster by the lymphatic and/or blood flow. Due to improved metabolismand/or circulation the cellulite may be treated in a short time and thevisual effect on skin appearance may be significantly enhanced.

In another aspect of the invention, the treatment by magnetic field maybe applied to the target structure simultaneously with theradiofrequency treatment to improve effects of the electromagnetictreatment inducing heat in the target structure.

The simultaneous application of magnet treatment and radiofrequencytreatment may be in two modes: a first mode may generate the magnetimpulses while radiofrequency treatment is active or another mode maygenerate radiofrequency treatment while the magnet treatment is not inan active stimulation period, i.e. the period of magnet treatment andradiofrequency treatment alternates. Both modes amplify the resultingeffect of the treatment. Therefore the results are achieved insignificantly shorter time than the same results achieved by separateapplications of the radio frequency and magnet treatments.

The simultaneous method of magnet treatment and radiofrequency treatmentof the target tissue may increase the peak magnetic component of theentire treatment resulting in improved heating of the target structureincluding containing higher water volume, e.g. skin. Due to increasedtemperature of skin, the production and/or remodeling of collagen and/orelastin fibers may be improved and the skin may be provided with ayounger, smoother and enhanced appearance. The effect of overheating themuscle is reduced by the improved blood flow.

In still another aspect of the invention, the treatment by magneticfield may be applied to the target structure after the treatment byelectromagnetic field to enhance and/or contribute to the effects ofradiofrequency treatment by influencing the target structure by magneticfield.

The magnetic field may treat the target structure to cause at leastpartial muscle contraction proximate to the target structure to improveblood flow and provide homogenous temperature distribution at highquality after creating a temperature distribution at lower quality byradiofrequency treatment.

The present device and methods of its operation are related to treatmentof a patient by magnetic and/or electromagnetic treatment. Theelectromagnetic treatment may be particularly radiofrequency treatment.The application of the magnetic and/or electromagnetic treatment may beprovided by at least one energy delivery element. The device may be usedfor treatment or focused remodeling of subcutaneous tissue by reducingnumber and/or value of lipid-rich cells, cellulite treatment, bodyshaping and/or contouring, muscle toning, skin tightening, collagentreatment, skin rejuvenation, wrinkle removing, reducing stretchmarks,breast lifting, lip enhancement, treatment of vascular or pigmentedlesions of the skin or hair removing.

The essential principle for this device is a fact that the energydelivery element, e.g. a magnetic field generating device such as a flatcoil which may be preferably circular shaped, may administer the samefunction as an electrode if it is provided by the high-frequency signal.Hence the coil may be used to generate a radiofrequency treatment. Thereason is that the frequency spectra of low-frequency signal used forgenerating the magnetic field is far different from frequency spectra ofhigh-frequency signal used for generating the electromagnetic field. Thesignals from at least one or more preferably two generators may beprovided successively, with some overlay or simultaneously due todifference of the frequency spectra. The frequency spectra ofhigh-frequency signal used for generating the electromagnetic field maybe in the range of ones of kHz to hundreds of GHz, more preferably inthe range of 500 kHz to 3 GHz, most preferably above 1 MHz around 3.4 or6.7 or 13.56 or 40.68 or 27.12 MHz or 434 MHz or 915 MHz or 2.45 GHz.The frequency spectra of low-frequency signal used for generating themagnetic field impulses may be in the range of 1 to 100 kHz, morepreferably in the range of 1.25 to 10 kHz, even more preferably in therange of 2 to 5 kHz, most preferably in the range of 3 to 4 kHz. Thelow-frequency signal is used for generating impulses of time-varyingmagnetic field. The repetition rate of the pulses may reach up to 700Hz, more preferably up to 500 Hz, most preferably in the range of 1 to300 Hz. The magnetic flux density of the magnet treatment is at least0.1 T, more preferably at least 0.5 T, even more preferably at least 1T, even more preferably at least 1.5 T, most preferably at least 2 T, orup to 7 T on the surface of the energy delivery element. The energydelivery element may be integrated within an applicator, such as patientsupport for maintaining the patient in sufficiently sitting or recumbentposition, e.g. a chair or a bed. The energy delivery element may bemoveable within the patient support. Alternatively the applicator may bemoveable, e.g. it may be attached to an articulated arm or it may bepreferably hand-held.

FIG. 17 illustrates a general design of a treatment device. Thetreatment device may include at least one energy delivery element 1701,e.g. a coil, preferably a flat coil; a low-frequency generator 1702 forgenerating a signal for generating a magnetic field by the energydelivery element 1701. The low-frequency generator may be a connectionof a switching device and an energy storage device. The switching devicemay be in serial connection with the energy storage device, preferably aparallel connection may be used. The treatment device further includesat least one high-frequency generator 1703 for generating a signal forgenerating an electromagnetic field. According to alternative embodimentonly one generator providing low and high frequency may be used.Additionally a combiner 1704 for transmitting the signals to the energydelivery element 1701 may optionally but not necessarily be used. Thecombiner 1704 may transmit the signals from generators 1702, 1703 to theenergy delivery element 1701. Furthermore the combiner may protect thehigh-frequency generator 1703 from the signal generated by thelow-frequency generator 1702 or vice versa. Hence the combiner mayprevent the signal from low-frequency generator to affect thehigh-frequency generator. The combiner may include at least onefiltering device, e.g. capacitive and/or inductive coupling, high-pass,low-pass, band-pass or band-stop such as notch filter; at least oneswitching device, e.g. a switch, a diode, MOSFET, JFET, IGBT, BIT or athyristor; or any combination thereof. Alternatively the combiner mayinclude a relay. In an exemplary embodiment the combiner 1704 mayinclude at least one coil and/or at least one capacitor, preferably aplurality of coils and/or a plurality of capacitors may be used as well.

The side of the energy delivery element closer to the patient may becovered by a layer of insulating material such as ceramic or epoxycoating, or bolus. The insulating material may provide electricalinsulation of the patient and mechanical protection of the energydelivery element.

In an alternative embodiment the treatment device may include aplurality of HF generators and/or a plurality of LF generators.

In an alternative embodiment the treatment device may include a humanmachine interface for the patient. The patient may control the power inthe treatment hence the patient may control e.g. temperature of thetarget biological structure or strength of the at least partial musclecontraction. Furthermore the patient may interrupt the treatment beforeany discomfort feeling may occur.

FIG. 18 illustrates the treatment device which may include a connectionto a power supply, a power source 1801, high-frequency generator 1802,low-frequency generator 1803, control unit 1804, human machine interface1805 and at least one energy delivery element 1806. According toalternative embodiment only one generator providing low and highfrequency may be used. The arrows illustrate the direction ofcommunication.

The power supply may provide energy for the treatment device via thepower source 1801. The power supply may be external, e.g. a plug, or itmay be integrally included within the treatment device, e.g. a battery.The power source 1801 may communicate with generators 1802, 1803. Thepower source 1801 may provide energy to electric components of thetreatment device, particularly to generators 1802, 1803 or to controlunit 1804. The power source 1801 may communicate with control unit 1804which may provide information about power necessary for the treatment.The power source 1801 may adjust the power for generators 1802, 1803following the information from control unit 1804 or alternatively basedon direct information from generator 1802 or generator 1803.

The control unit 1804 may communicate with LF generator. LF generatormay provide LF signal to energy delivery element 1806 to generatemagnetic treatment. The LF generator 1803 may provide informationreferred to treatment process to the control unit 1804, e.g. energy lossfrom one impulse. In an exemplary embodiment the control unit 1804 maysend instruction to power source 1801 to provide the LF generator 1803by the energy amount equaling the energy loss. Alternatively the controlunit 1804 may control recharge of the LF generator.

The energy delivery element 1806 may include at least one sensor, e.g. atemperature sensor. The energy delivery element may provide informationto control unit 1804, HF generator 1802 and/or to LF generator 1803.

The control unit 1804 may communicate with HF generator 1802 to provideinstructions for HF generator 1802. HF generator may provide HF signalfor energy delivery element 1806 to generate RF treatment. The HFgenerator 1802 may provide information referred to treatment process tothe control unit 1804, e.g. temperature of the energy delivery element1806. In one exemplary embodiment RF energy transfer may be optimizedprior to the treatment. In an exemplary embodiment the HF generator 1802may include an internal power source for adjusting energy for energydelivery element 1806. Alternatively, more than one energy deliveryelement 1806 may be used. When using two or more energy deliveryelements, the at least one energy delivery element may deliver magneticfield, the at least one energy delivery element may deliverelectromagnetic field (e.g. radiofrequency field); in still anotherembodiment each energy delivery element may provide both magnetic fieldand electromagnetic field (e.g. radiofrequency field) for magnetic andelectromagnetic treatment.

The control unit 1804 may be in communication with human machineinterface 1805. The human machine interface 1805 may include outputtinginterface for providing information for the operator and/or the patient.The outputting interface may include audio output, e.g. a speaker;visual output, e.g. a display or any combination. The outputtinginterface may provide a notification for the operator and/or the patientin a human perceptible form such as beep, flashing light, color changeor mechanical signal.

The human machine interface 1805 may include at least one input element,e.g. touch member such as touchscreen, keyboard, control member foradjusting the treatment, for providing the information from operator.The operator may adjust e.g. a treatment protocol or may adjusttreatment parameters following the patient's need.

In an alternative embodiment the treatment device may include at leasttwo control units. One control unit may administer HF generator. Secondcontrol unit may administer LF generator. In this exemplary embodiment acommunication link between both control units may be established.

The energy delivery element may be used as an energy source for anotherpart and/or electric member of the treatment device. The energy deliveryelement may be used as a part of transformer or antenna. In an exemplaryembodiment illustrated in FIG. 19A the energy delivery element 1901 maybe surrounded by a loop of conductor 1902 for inducing a voltage forproving power for the other electric member 1903. The loop may inducethe voltage in order of tens Volts, e.g. 50 V. The induced voltage maybe used for powering of electric member, e.g. a cooling device such asfan, blower or pump used for moving a cooling media, or Peltier cooler;or any electric member providing an additional treatment such as LED.FIG. 19B illustrates an exemplary embodiment of using induced voltagefor powering a plurality of light sources providing optical treatment.The energy delivery element 1901 may be encircled by a loop of conductor1902 for inducing a voltage to provide energy for the plurality of LED1903 providing optical treatment for the patient. Alternatively at leastone LED may be used for generating a light from visible spectra to beused for targeting the treatment. The power loss of the coil may be upto ones of Watts, more preferably up to 5 W, most preferably around 1 W.

FIG. 20 illustrates a cross section of an exemplary embodiment of energydelivery element 2001, particularly a flat coil comprising a pluralityof insulated wires 2002. The coil may be wound around a magnetic core2003 which may be protruded out from the coil up to several centimeters,more preferably in the range of 0.1 to 10 cm, even more preferably inthe range of 0.5 to 7 cm, most preferably in the range of 1 to 5 cm. Inan alternative embodiment the magnetic core may be around the coil. Themagnetic field may be profiled, saturated and/or delivered to closerproximity of the patient by the protruding magnetic core.

In an exemplary embodiment the treatment device may include one energydelivery element. The energy delivery element, e.g. a flat coil, may beused for providing magnetic treatment and RF treatment. The energydelivery element may be provided by high-frequency and by low-frequencysignal. The RF treatment may be unipolar. The high-frequencyelectromagnetic field may be radiated to the target biologicalstructure. The applicator may be moveable to increase the homogeneity ofthe treatment. The scanning movement may be preferably used.Alternatively the movement of the applicator may follow a predeterminedpattern corresponding to a treated body part. The movement of theapplicator may be manual and/or automatically provided by a manipulatingdevice, e.g. robotic arm or scanning mechanism.

The radiofrequency treatment may be applied by the energy deliveryelement to the target biological structure in three modes. One mode maybe simultaneous application of RF treatment and magnetic treatment.Another mode may be separate RF treatment and magnetic treatment, RFand/or magnetic treatment may be applied in various sequences or it mayalternate. Still another mode may be application of RF and magnetictreatment with some overlay. In an exemplary application the RFtreatment may be applied prior a magnetic treatment. In anotherexemplary application the RF treatment may be applied after magnetictreatment.

In an alternative embodiment the treatment device may include areference electrode to provide a monopolar application of RF treatmentby the energy delivery element.

FIG. 21A illustrates an exemplary embodiment of the magnetic fieldgenerating device 2101 powered by LF generator which is encircled by anelectrode 2102 for providing RF treatment. In an alternative embodimentillustrated in FIG. 21B the magnetic field generating device 2101powered by LF generator may be encircled by a plurality of electrodes2102 powered by HF generator to provide RF treatment. In this particularexemplary embodiment two electrodes are semicircular shaped. Stillanother exemplary embodiment including the magnetic field generatingdevice powered by LF generator encircled by a plurality of round-shapedelectrodes powered by at least one HF generator to provide RF treatment.Alternatively the plurality of electrodes may be powered by a pluralityof HF generators. These exemplary embodiments may exclude combiner. Theseparation of the HF and LF signals may be provided by mechanical layoutof the energy delivery elements, e.g. magnetic field generating deviceor electrode.

The treatment may be provided by contactless application. Alternativelythe treatment may be administered in contact way or by indirect contactway by using a bolus/spacing object. The spacing object may bepreferably transparent for high power magnetic field and it may includeinner space filled with at least one substance. The spacing object mayprovide optimal distribution RF field used for treatment it may providea cooling of the skin which it contacts.

The at least two electrodes may be connected by at least one capacitorwhich may provide a capacitive connection between the electrodes. FIG.22A illustrates an exemplary embodiment of the magnetic field generatingdevice 2201 powered by LF generator. The magnetic field generatingdevice 2201 may be encircled by a plurality of electrodes 2202 which arepowered by one HF generator. The electrodes may be of various shapes,e.g. angular such as square or rectangle; or round such as circular oroval. The plurality of electrodes 2202 may be connected by a pluralityof capacitors 2203. The at least one capacitor provides a capacitivecoupling between electrodes hence the plurality of electrodes mayprovide a treatment as a plurality of unipolar electrodes. On the otherhand the electrodes may not be influenced by a magnetic field generatedby magnetic field generating device.

The at least two electrodes may be connected by at least one inductivemember, e.g. a coil. FIG. 22B illustrates an exemplary embodiment of themagnetic field generating device 2201 powered by LF generator which isencircled by two electrodes 2202 which are powered by one HF generator.The electrodes 2202 may be connected by a coil 2204 which may provideseparation of the electrodes 2202 powered by HF generator hence the RFtreatment may be bipolar. On the other hand the coil 2204 providesconnection of the electrodes 2202 for magnetic field generated bymagnetic field generating device 2201 hence the coil and the electrodes2202 may cause the same effect as a conductor loop (dotted line) aroundthe magnetic field generating device 2201. The voltage induced in theloop may be use for powering of electric member 2205 as mentioned above.

FIG. 23A illustrates an exemplary embodiment of the energy deliveryelement 2301 powered by LF generator. The energy delivery element 2301may be wound around an electrode 2302 providing RF treatment. Preferablythe energy delivery element may be wound around a plurality ofelectrodes. FIG. 23B illustrates an exemplary embodiment of thetreatment device including two electrodes 2302 in the energy deliveryelement 2301 which is powered by LF generator. Alternatively at leasttwo electrodes within the energy delivery element may be connected by anenergy storage device. The energy storage device may be designed to beof low resistance value when high-frequency signal (frequency of RFsignal) is provided and/or to be of high resistance when thelow-frequency signal (frequency of magnetic signal) is provided. In thepreferred embodiment the energy storage device may conduct asshort-circuit when powered by high-frequency signal and as infiniteresistor when power by low-frequency signal.

The treatment device may include a mathematic method including at leastone of calculation and/or statistic method for monitoring correctness ofthe treatment and/or for monitoring the heat produced by the treatmentdevice. The mathematic method may monitor at least one characteristicquantity of at least one operation parameter. The mathematic method maybe used for determining heat generated by the energy delivery element.The generated heat may be used for additional heating biologicalstructures in proximity. Alternatively, the energy delivery element maybe less cooled to reach higher temperature for improved heating of thepatient.

The applicator may be statically positioned to a predefined position totreat the target biological structure. Alternatively the applicator maybe moveable during the treatment to treat larger area of the patientcompared to treatment in static position. The RF energy transfer may beoptimized prior to the treatment if the applicator is staticallypositioned and/or the treatment is provided in contact way. However, thecontinual optimizing of the energy transfer may be preferred forproviding optimal and/or highly effective treatment to shorten thetreatment duration, to improve the treatment effect and/or to achievethe desired results in shorter time period. Moreover the continualenergy transfer optimizing may eliminate incorrect energy transfercaused by patient movement, e.g. caused by breath, and/or change ofphysiological conditions, e.g. caused by sweat, improved blood perfusionor increased temperature.

The treatment device may include a plurality of energy deliveryelements, e.g. two, three, four or more. However, the even number ofenergy delivery elements may be used in the preferred embodiment. The atleast two magnetic field device may provide a bipolar RF treatment,alternatively monopolar treatment may be provided as well. The bipolartreatment may provide homogenized temperature distribution in the targetbiological structure.

FIG. 24 illustrates the treatment device which may include a connectionto a power supply, a power source 2401, high-frequency generator 2402,low-frequency generator 2403, control unit 2404, human machine interface2405, transmatch 2406, balun 2407 and at least one energy deliveryelement 2408. The components illustrated by dotted line may be optionaland may be excluded from the treatment device. According to alternativeembodiment only one generator providing low and high frequency may beused. The arrows illustrate the direction of possible communication.

Transmatch may optimize the energy transfer to the patient. A functionof balun is to transform unbalanced signal to balanced signal.

The power supply may provide energy for the treatment device via thepower source 2401. The power supply may be external, e.g. a plug, or itmay be integrally included within the treatment device, e.g. a battery.The power source 2401 may provide energy to electric components of thetreatment device, particularly to both generators 2402, 2403 or tocontrol unit 2404. The power source 2401 may communicate with controlunit 2404 which may provide information about power necessary for thetreatment. The power source 2401 may adjust the power for generators2402, 2403 following the information from control unit 2404 oralternatively based on direct information from generator 2402 orgenerator 2403

The control unit 2404 may communicate with LF generator 2403. LFgenerator 2403 may provide LF signal to at least one energy deliveryelement 2408 to generate magnetic treatment. The LF generator 2403 mayprovide information referred to treatment process to the control unit2404, e.g. energy loss from one impulse. In an exemplary embodiment thecontrol unit 2404 may send instruction to power source 2401 to providethe LF generator 2403 by the energy amount equaling the energy loss.Alternatively the control unit 2404 may control recharge of the LFgenerator.

The energy delivery element 2408 may include at least one sensor, e.g. atemperature sensor. The energy delivery element may provide informationto control unit 2404, HF generator 2402 and/or to LF generator 2403.

The control unit 2404 may communicate with HF generator 2402 to provideinstructions for HF generator 2402. HF generator 2402 may provide HFsignal for at least one energy delivery element 2408 to generate RFtreatment. The HF signal may be transferred via transmatch 2406. The HFgenerator 2402 may provide information referred to treatment process tothe control unit 2404, e.g. temperature of the at least one energydelivery element 2408 and/or information provided by transmatch 2406. Inexemplary embodiment RF energy transfer may be optimized prior to thetreatment. However, the continual optimizing of the energy transfer maybe preferred for providing optimal and/or highly effective treatment toshorten the treatment duration, to improve the treatment effect and/orto achieve the desired results in shorter time period. Moreover thecontinual energy transfer optimizing may eliminate incorrect energytransfer caused by patient movement, e.g. caused by breath, and/orchange of physiological conditions, e.g. caused by sweat, improved bloodperfusion or increased temperature. In an exemplary embodiment the HFgenerator 2402 may include an internal power source for adjusting energyfor at least one energy delivery element 2408.

Alternatively, more than one energy delivery element 2408 may be used.When using two or more energy delivery elements, the at least one energydelivery element may deliver magnetic field, the at least one energydelivery element may deliver electromagnetic field (e.g. radiofrequencyfield); in still another embodiment each energy delivery element mayprovide both magnetic field and electromagnetic field (e.g.radiofrequency field) for magnetic and electromagnetic treatment.

The control unit 2404 may be in communication with human machineinterface 2405. The human machine interface 2405 may include outputtinginterface for providing information for the operator and/or the patient.The outputting interface may include audio output, e.g. a speaker;visual output, e.g. a display or any combination. The outputtinginterface may provide a notification for the operator and/or the patientin a human perceptible form such as beep, flashing light, color changeor mechanical signal.

The human machine interface 2405 may include at least one input element,e.g. touch member such as touchscreen, keyboard, control member foradjusting the treatment, for providing the information from operator.The operator may adjust e.g. a treatment protocol or may adjusttreatment parameters following the patient's need.

The control unit 2404 may be in communication with transmatch 2406. Thecontrol unit 2404 may control the function of transmatch 2406.Transmatch 2406 may be provided by instructions from control unit 2404to optimize the energy transfer to the patient. The transmatch 2406 mayinclude an energy source to be able to adjust the energy provided to theat least one energy delivery element 2408.

In an alternative embodiment the transmatch 2406 may be excluded fromthe treatment device. The embodiment may be used for contact treatmentor alternatively for contactless treatment. The energy transfer may beoptimized prior the treatment.

In an alternative exemplary embodiment the transmatch may be the energydelivery element. The energy transfer may be optimized by adjusting e.g.transformation ratio.

The treatment device may include balun in various locations. In oneexemplary embodiment unbalanced signal from HF generator 2402 may betransformed in the balun 2407 to balanced signal which further continuesto transmatch 2406 and further to at least one energy delivery element2408.

In an alternative exemplary embodiment the balun 2409 may be located inthe transmatch 2406 or between transmatch 2406 and energy deliveryelement.

In alternative embodiment the balun may be excluded.

FIG. 25A illustrates an exemplary embodiment of the treatment deviceusing a plurality of energy delivery elements. In this particularexemplary embodiment, two energy delivery elements may provide bothmagnetic field and electromagnetic field (e.g. radiofrequency field) formagnetic and electromagnetic treatment. The treatment device includeshigh frequency generator 2501, transmatch 2502, balun 2503, lowfrequency generator 2504, combiner 2505, at least two energy deliveryelements 2506.

The HF generator 2501 may provide HF signal to transmatch 2502 which mayadjust the HF signal to optimize the energy transfer between thetreatment device and the patient. The optimized HF signal may bedirected to balun 2503 and to combiner 2505. In an alternativeembodiment the balun 2503 may be incorporated in transmatch 2502 or maybe between HF generator 2501 and transmatch 2502.

The at least one LF generator 2504 may provide LF signal to at least onecombiner 2505. The combiner 2505 may provide both signals, from HFgenerator 2501 and from LF generator 2504, to energy delivery element2506. The energy delivery element 2506 may provide energy to treat thetarget biological structure. In the particular embodiment the energytransfer (illustrated by dotted line) is defined by position of theenergy delivery elements 2506. The energy transfer may be capacitiveand/or inductive.

In the exemplary embodiment illustrated in FIG. 25A the treatment deviceincludes two loops 2507, 2508 each including HF signal, LF signal,energy delivery element. In an alternative embodiment the treatmentdevice may include one common LF generator for both loops 2507, 2508.According to alternative embodiment only one generator providing low andhigh frequency may be used.

The HF generator 2501 may provide HF signal to transmatch 2502 which mayadjust the HF signal to optimize the energy transfer between thetreatment device and the patient. The optimized HF signal may bedirected to combiner 2505. LF generator 2504 may provide LF signal tocombiner 2505. The combiner 2505 may provide both signals, from HFgenerator 2501 and from LF generator 2504, via balun 2503 to energydelivery element 2506. The energy delivery element 2506 may provideenergy to treat the target biological structure. In the particularembodiment the energy transfer (illustrated by dotted line) is definedby position of the energy delivery elements 2506. The energy transfermay be capacitive and/or inductive.

In an alternative embodiment the exemplary treatment device may includeone LF generator. According to alternative embodiment only one generatorproviding low and high frequency may be used.

Alternatively, the transmatch may be a incorporated in balun. The energytransfer may be optimized by e.g. adjusting transformation ratio.

In still another exemplary embodiment with respect to 25A and 25B thecombiners may be coupled. The coupling may be capacitive and/orinductive. Alternatively one combiner may be used. In anotheralternative embodiment the combiner may be excluded. The separation ofthe signals may be provided by mechanical layout of the energy deliveryelements as described above.

The plurality of energy delivery elements may be positionedindependently to each other to provide a treatment for the patientfollowing the patient's needs. The position of the energy deliveryelement may be placed by the operator. The plurality of energy deliveryelements may be in a plurality of applicators, e.g. each applicatorincludes at least one energy delivery element.

Alternatively the plurality of energy delivery elements may bepositioned dependent to each other, preferably in a predefined pattern.The position of the plurality of the energy delivering elements mayprovide a treatment characterized by a phase shift. FIG. 26A illustratesan exemplary embodiment of the treatment with phase shift. The treatmentdevice includes HF/LF generator 2601 for providing a signal for aplurality of energy delivery elements 2602. The signal for each energydelivery element may be phase shifted with respect to each other togenerate a specific treatment profile which may be adjusted followingthe patient's needs. FIG. 26B illustrates an exemplary application. TheHF/LF generator 2601 provides the signal for three energy deliveryelements 2602 which may be preferably flat coils. The energy deliveryelements are oriented with respect to each other. The HF signal may beprovided to the energy delivery elements phase shifted to create aspecific profile of the treatment. The phase shift may be e.g. 60°. Thephase shift may be adjusted by the operator and/or by the patientfollowing the patient's needs. In another alternative embodiment thephase shift may be dependent on the number of energy delivery elements.

The treatment device may include a plurality of applicators. Eachapplicator may include at least one energy delivery element. Theapplicator may be moveable during the treatment, the energy deliveryelement may be movable within the at least one applicator as well.

Alternatively the plurality of energy delivery elements may bepositioned within one applicator having form of mechanical holder. Theshape of the applicator having form of mechanical holder may beadjustable, e.g. the applicator may include at least one moveable part.In a preferred embodiment the applicator having form of mechanicalholder may provide spatial arrangement of the energy delivery elementsin one axis, two axes or three axes and/or provide tilting and/orrotation. The applicator having form of mechanical holder may providefixation of the at least one energy delivery element in one position.The moveable parts may be connected by sliding mechanism and/or by ajoint mechanism. The at least one part of the applicator may include atleast one energy delivery element. The applicator may be adjustablefollowing the treated area and/or biological structure.

The static position of the at least one applicator may be provided by apositioning member. The positioning member may be e.g. an arm or anadjustable flexible belt. The positioning member may include a bucklefor adjusting the length of the belt. The applicator may be placedwithin predefined locations of the belt. Alternatively the applicatormay be shaped to be moveable along the positioning member, e.g. theshape of the applicator may be preferably concave, e.g. V-shaped orU-shaped. The positioning member may be inserted itself into theconcavity of the applicator. The position of the applicator may beadjusted by limited movement along the positioning member because thepositioning member may be used as guiding member. However, theapplicator may not be fixed to a particular static position. Theposition of the applicator may be dynamically adjusted during thetreatment following the patient's needs. The position of the applicatormay be adjusted manually by the operator, or automatically by thetreatment device. In one exemplary embodiment a plurality of applicatorsmay be used for treating larger body part, e.g. buttocks, abdomen orthigh.

Alternatively, the at least one energy delivery element, e.g. a coil,may be positioned below the at least one electrode. The energy deliveryelement may be positioned in between the electrode and the patient.

The at least one energy delivery element may influence at least oneanother energy delivery element while using the plurality of energydelivery elements. The correct treatment may be controlled via themathematic method used for monitoring the at least one characteristicquantity of the operation parameter. The mutual positon of the energydelivery elements may be evaluated by the mathematic method as well.Hence the mathematic method may prevent providing the patient withincorrect treatment caused by incorrect position and/or orientation ofat least two energy delivery elements. Furthermore the mathematic methodmay prevent the treatment device from affecting any conductive parts bythe generated treatment, e.g. an additional heat may be generated.

The mathematic method may be further used for determining temperatureand/or heat generated by at least one energy delivery element. Hence themathematic method may be used for controlling a cooling of the energydelivery element, e.g. flow of the cooling media may be regulated. Theheat generated by the energy delivery element may be further used forheating the patient.

The treatment system for creating the electromagnetic field can usebipolar electrodes, where electrodes alternates between active andreturn function and where the thermal gradient beneath electrodes isduring treatment almost the same. The system may alternatively usemonopolar electrodes, where the return electrode has sufficiently largearea in contact with skin of patient and is typically positioned arelative larger distance from the active electrode. A unipolar electrodemay also optionally be used.

Referring now to FIG. 27, a system 270 applies electromagnetic energythrough a skin layer, such as the epidermis, and to the underlyingdermal and/or sub dermal tissue, and underlying collagen tissue, causingacceleration of lipolysis and collagen remodeling. The system mayinclude 6 blocks. The power supply 271 is connected to a power source.An HF generator (high frequency generator) 272 and a transmatch andgenerator control unit 273, and a microprocessor control unit with userinterface 274, are connected to the power supply 271. The HF generator272 may generate an electromagnetic field at 13.56 or 40.68 or 27.12MHz, or 2.45 GHz or optionally at other frequencies as well. The 13.56,27.12 and 40.68 MHz and 2.45 GHz frequencies avoid creating radiointerference, as these frequencies are exclusively assigned as free oropen frequencies.

The microprocessor control unit with user interface 274 providescommunication between the transmatch and generator control unit 273 anduser interface, which may be a touch screen on the device display.

The transmatch and generator control unit 273 receives information fromthe operator via the control unit and regulates the operation of the HFgenerator 272 and the transmatch 275. The transmatch transmits HF to abalun transformer 276, which converts unbalanced impedance to balancedimpedance. This processed signal goes to two capacitive applicators 277,which may be positioned 0.5 cm or higher above the surface of the skinor applied on dielectric or insulating, non-conductive material which isin contact with the skin surface.

FIG. 28 is a schematic representation of a heat distribution under theskin. One or more applicators 281 create an electromagnetic field. Thiselectromagnetic field crosses through the skin 283, subcutaneous fat 284and muscle 285 or the bone 286. Capacitive applicators 281 provide deepheating, which heats selectively only structures with low volume, ofwater. A spacer 282 such as a towel, gauze pad, foam pad, cloth pad andanother porous or air permeable materials may be placed on the skin,with the applicator then placed on top of the spacer 282. The spacer maybe made from three-dimensional material with high air permeabilityformed by two square fabrics with preferably low square densitiesconnected by tough filaments. This automatically sets the separationdistance between the applicator and the skin, and prevents theapplicator from touching the skin. The spacer 282 may be made of variousdielectric or electrically non-conductive materials. The spacer 282 istypically dry in use. Alternatively, a reusable or a disposable spacermay be attached to the applicator. For example, the spacer may compriseposts, a frame, or other structure on the applicator that contacts theskin, while keeping the active surface of the applicator spaced apartfrom the skin. As described and claimed here, such spacing elements areadditional elements and not part of applicator. The methods may beperformed with no part or surface of the actuator in contact with theskin.

Dielectric loss is created, as part of an AC electromagnetic field poweris converted to heat in the dielectric. During this process, ionsaccelerate and collide, polar molecules rotate, non-polar moleculesundergo distortion and these movements produce thermal energy. Skin andmuscle are largely not affected by electromagnetic field 287 as theycontain water and the blood, circulartion provides for cooling. Bone 286gets little if any heating because the applicators 281 are positioned tocreate a field only on the upper structures. The lipid cells of theadipose tissue contain less water than any surrounding tissue and aretherefore heated at higher level than any surrounding tissue.

An air gap or material with high air permeability may be placed betweenthe skin and the applicator. This arrangement uses the humanthermoregulatory system for cooling and avoids the need of artificialcooling of the skin. Additionally to enhance evaporation, airflowcirculation between patient's skin and the applicator may be increasedusing a stream of chilled or room temperature air.

If more than one applicator is used, applicators may be positioned onopposite sides of the patient. A spacer may be positioned between one ormore applicator and the skin of the patient. The electromagnetic wavesmay be transmitted in the range of 13.553-13.567 or 26.927-27.283 or40.66-40.70 MHz or 2.4-2.5 GHz from the applicator into the subcutaneoustissue. The temperature of the skin surface may be increased to about32-45° C.

One or more of the applicators may have a temperature sensor whichmeasures and monitors the temperature of the treated tissue. Temperaturecan be analyzed by a microprocessor control unit. The temperature sensormay be a contactless sensor (e.g. infrared temperature sensor), contactsensor (e.g. resistance temperature detector) or invasive sensor (e.g. athermocouple) for exact temperature measuring of deep or shallow tissueof human skin. The microprocessor controller may use algorithms tocalculate the deep or shallow temperature based on the surfacetemperature of the skin. A feedback system may be used to measure andcontrol temperatures on the skin surface or below the skin surface. Thefeedback system may control the temperature to a predetermined level,for example by adjusting power, airflow circulation, phase shifting,supplemental magnetic field, and perhaps other parameters, orcombinations of them.

The present device and method use a combination of non-invasive,preferably contactless, applications of different methods for enhancinghuman appearance. Particularly, the present invention uses a combinedtreatment by time-varying magnetic field and optical waves.

The treatment is defined by application of electromagnetic waves ofwavelength in the range of 635 to 1100 nm, with maximal power fluxdensity up to 100 W/cm². Alternatively, in the case of pulse light, thepower flux density may be up to 100 W/cm² with light pulses lasting upto 300 ms, however, preferably in the range of 1 to 20 ms. Opticaltreatment may be used for inducing heat generation within the adiposecells over physiological temperature.

The treatment by optical waves may be combined with application ofmagnetic treatment inducing at least partial muscle contraction.

The presented methods enable aesthetic applications providingsignificant reduction of number and/or volume of adipose cells and causecircumferential reduction i.e. a reduction of the size of the treatedbody area. Furthermore, the treatment method induces at least partialmuscle contraction to provide muscle toning, muscle shaping, bodycontouring, body shaping or skin tightening effect. Additionally, strongmuscle contractions at high repetition rate may cause mechanicalmovement of all the layers in proximity of the contracted muscle. Themethod therefore may cause remodeling and/or neogenesis of the collagenand elastin fibers.

Optical treatment may selectively heat the target biological structure.Hence optical treatment may remove and/or remodel adipose tissue.Before/after, with some overlap or simultaneously the magnetic treatmentof the target biological structure may induce at least partial musclecontraction within the target biological structure to remodel theadipose tissue by natural adipose tissue catabolism. Adipose tissuecatabolism may be caused by apoptosis and/or necrosis of the adipocytes.The muscle contraction caused by induced eddy current is equivalent to anatural contraction. The adipose tissue may be reduced in natural way.Additionally, the muscle may be toned and/or shaped in a natural way.Therefore the effect resulting in body shaping and/or contouring may besignificantly improved.

The present methods provide advanced approaches in aestheticapplications. Combined methods of treatment by optical treatment andtreatment by magnetic field are used. The optical treatment may includetreatment by optical waves. The magnet treatment may be provided bypermanent magnets, electromagnetic devices generating a static magneticfield or preferably by magnetic devices generating time-varying magneticfield. In the preferred application the method may combine treatment bya pulsed magnetic field and optical treatment. The application is notlimited by the recited combination so the combined method may includemagnetic treatment and any treatment by electromagnetic field such asradiofrequency waves, e.g. microwaves, short waves or long waves.

The basic parts of the optical irradiation system include a hardwarepanel and an optical waves generating device or multiple optical wavesgenerating devices. The optical waves generating device may be arrangedin an array. The optical waves generating devices may be attached toeach other or alternatively be individually mounted on dedicatedsupports. A scanning system may also be one of the options.

At least one optical wave generating device and a magnetic fieldgenerating device are provided. An optical treatment device may includeat least one energy source and/or connection to the energy source, ahardware panel for controlling the optical treatment device and anoptical waves generating device. Non limiting examples of optical wavesgenerating device that may be used include light emitting diodes,lasers, laser diodes, different types of lamps and filtered lamps orcombinations thereof. The treatment device may include at least oneoptical waves generating device, more preferably a plurality of opticalwaves generating devices of wavelength from ultraviolet, visible andinfrared spectrum ranges. The wavelength may be in the range of 190 to13000 nm, preferably in the range of 290 to 3000 nm, more preferably inthe range of 400 to 1500 nm, even more preferably in the range of 550 to1450 nm, particularly wavelengths about 915, 1064, 1208 and 1715 nm maybe used.

The plurality of optical waves generating devices may generate opticalwaves simultaneously. The plurality of generated optical waves mayinterfere. Alternatively the plurality of optical waves generatingdevices may generate a plurality of independent optical waves atdifferent times, preferably in sequences. The plurality of optical wavesgenerating devices may be arranged in a predefined pattern within anapplicator, e.g. in an array or a matrix.

The optical treatment applicator may be preferably external (e.g.hand-held). Alternatively, the optical treatment applicator may be anintegral part of the optical treatment device (e.g. chair/bedimplemented). Additionally, optical delivery elements, such as opticalwaveguides, light tubes or optical gel, may be used.

The magnetic treatment applicator may be an integral part of thetreatment device, or it may be preferably external part of the treatmentdevice (e.g. hand-held), alternatively the magnetic treatment applicatormay be an integral part of the magnetic treatment device (e.g. chair/bedimplemented).

According to one embodiment the magnetic treatment and optical treatmentmay be provided by at least two separate devices, i.e. at least onedevice for administering the magnetic treatment and at least one devicefor administering the optical treatment. The optical treatment may beapplied to target biological structure prior, after or with some overlaywith magnetic treatment. Alternatively optical treatment may be appliedsimultaneously with magnetic treatment. The time consequences of thetreatment are described below.

FIG. 29 illustrates an exemplary embodiment providing combined treatmentby magnetic field and optical treatment. The optical treatment isadministered by optical treatment device 2901 (dotted line) including aconnection to an energy source 2902 and a hardware panel 2903 forcontrolling the optical treatment. The hardware panel 2903 is connectedwith optical waves generating device 2904 within an optical treatmentapplicator 2905 (dotted line). The magnetic treatment is administered bymagnetic treatment device 2906 (dotted line) including a connection toan energy source 2907 and a hardware panel 2908 for controlling thetreatment by magnetic field. The hardware panel 2908 is connected withmagnetic field generating device 2909 within a magnetic treatmentapplicator 2910 (dotted line).

In an alternative embodiment the at least one optical waves generatingdevice may be in the treatment device. The optical waves may bedelivered to the applicator and/or to the target biological structure bya waveguide.

According to another embodiment the magnetic treatment and opticaltreatment may be provided by one device. The combined treatment providedby one device may be administered by at least one applicator. FIGS. 30Aand 30B illustrate exemplary embodiments providing the combinedtreatment by two applicators providing different types of treatment,i.e. magnetic and optical treatment, to the target biological structure.FIGS. 31A and 31B illustrate exemplary embodiments providing thecombined treatment by one applicator providing magnetic and/or opticaltreatment to the target biological structure.

FIG. 30A illustrates one exemplary embodiment of a combined treatmentdevice providing magnetic and/or optical treatment by at least twoapplicators. The combined treatment device 3001 (dotted line) includes aconnection to an energy source 3002 providing energy for a magnetictreatment and for an optical treatment. The optical treatment iscontrolled by a hardware panel for optical treatment 3003 which controlsan optical waves generating device 3004 within an optical treatmentapplicator 3005 (dotted line). The magnetic treatment is controlled by ahardware panel for magnetic treatment 3006 which controls a magneticfield generating device 3007 within a magnetic treatment applicator 3008(dotted line).

In an alternative embodiment the at least one optical waves generatingdevice may be in the treatment device. The optical waves may bedelivered to the applicator and/or to the target biological structure bya waveguide.

FIG. 30B illustrates another exemplary embodiment of a treatment deviceproviding magnetic and/or optical treatment by at least two applicators.The combined treatment device 3011 (dotted line) includes a connectionto an energy source 3012 providing energy for the magnetic treatmentand/or for the optical treatment. Optical and/or magnetic treatments arecontrolled by a hardware panel 3013. The hardware panel 3013 controls anoptical waves generating device 3014 within an optical treatmentapplicator 3015 (dotted line). Further the hardware panel 3013 controlsa magnetic field generating device 3016 within a magnetic treatmentapplicator 3017 (dotted line).

In an alternative embodiment the optical waves generating devices may bein the treatment device. The optical waves may be delivered to theapplicator and/or to the target biological structure by a waveguide.

FIG. 31A illustrates still another exemplary embodiment of a treatmentdevice providing magnetic and/or optical treatment by at least oneapplicator. The combined treatment device 3101 (dotted line) includes aconnection to an energy source 3102 providing energy for the magnetictreatment and/or for the optical treatment. The optical treatment iscontrolled by a hardware panel for optical treatment 3103 which controlsan optical waves generating device 3104 within an applicator 3105(dotted line). The magnetic treatment is controlled by a hardware panelfor magnetic treatment 3106 which controls a magnetic field generatingdevice 3107 within the applicator 3105 (dotted line). The applicatorprovides combined treatment.

In an alternative embodiment the optical waves generating devices may bein the treatment device. The optical waves may be delivered to theapplicator and/or to the target biological structure by a waveguide.

FIG. 31B illustrates still another exemplary embodiment of a treatmentdevice providing magnetic and/or optical treatment by at least oneapplicator. The combined treatment device 3111 (dotted line) includes aconnection to an energy source 3112 providing energy for the magnetictreatment and/or for the optical treatment. Optical and/or magnetictreatment is controlled by a hardware panel 3113. The hardware panel3113 controls an optical waves generating device 3114 and magnetic fieldgenerating device 3115 within an applicator 3116 (dotted line).

In an alternative embodiment the at least one optical waves generatingdevice may be in the treatment device. The optical waves may bedelivered to the applicator and/or to the target biological structure bya waveguide.

According to still another embodiment the magnetic field generatingdevice may be used as an energy source for providing energy to anotherpart of the treatment device, e.g. an optical waves generating devicesuch as light-emitting diode (LED). FIGS. 32A and 32B illustrateexemplary embodiments of the magnetic field generating device which maybe used as power supply. The magnetic field generating device 3201 maybe surrounded by a conductor loop 3202. The time-varying magnetic fieldgenerated by magnetic field generating device 3201 induces eddy currentsin the conductor loop 3202 within proximity of the magnetic fieldgenerating device 3201. The induced current in the conductor loop 3202may be used for providing energy to another powered part of thetreatment device, particularly in the applicator, or another treatmentdevice, such as at least one optical waves generating device. FIG. 32Aillustrates an exemplary embodiment of magnetic field generating device3201 surrounded by a conductor loop 3202. The conductor loop 3202 may beconnected to a plurality of optical waves generating devices 3203. FIG.32B illustrates another exemplary embodiment of the magnetic fieldgenerating device 3201 surrounded by the conductor loop 3202. Theconductor loop 3202 provides the energy to the optical waves generatingdevice 3203. The optical waves generating device may be distanced fromthe conductor loop and may be external to the applicator including themagnetic field generating device 3201 and the conductor loop 3202.

Biocompatibility issues or hot spot generation may be overcome bytransmitting electromagnetic energy into the target biological structurewithout physical contact with the patient. Contactless application ofmagnetic and/or optical treatments may provide sufficient passivecooling of the biological structure by circulating air.

In some indications, it may be advantageous to treat deeper adiposetissue by magnetic field simultaneously with the treatment of moresuperficial layers of the skin by optical waves.

An air gap or bolus material with high air permeability may be placedbetween the skin and the applicator. The material may be preferablytransparent to the optical waves. This arrangement uses the humanthermoregulatory system for cooling and avoids the need of artificialcooling of the skin. Optionally, the skin may be cooled via a stream ofchilled or ambient temperature air. The human thermoregulatory systemenables perspiration and other body fluids to evaporate and cool thesurrounding skin. The application of electromagnetic waves iscontactless. Therefore sweat accumulation and/or hot spot creation areavoided. Use of cooling fluids or gels is not necessary but may beoptionally used. Cost of the treatment is reduced and patient comfort isimproved. The applicator may be in direct or indirect contact withpatient's skin. A bolus device may be used for providing indirectcontact of the applicator with the target biological structure. A bolusmay be filled with a material, preferably a fluid, influencing thepropagation of the electromagnetic waves and/or homogenizing thetemperature distribution of the patient's skin. Alternatively the bolusmay deliver the electromagnetic waves to the target biologicalstructure, e.g. a waveguide.

Cooling may be provided by positioning an air moving device proximate tothe skin. The air moving device may be attached to or implemented intothe applicator. Air moving device may be any kind of fan, ventilator orblower. The blower may include an air tube connected to air source formoving air through the air tube to the patient's skin. The air sourcemay alternatively be cooled to provide cooled air. Alternatively, airsuction may be also used as an active cooling method.

One or more applicators may move in the vicinity of the patient's body.The movement may be provided in various speed and/or acceleration. Itmay be moved in at least one direction, e.g. longitudinal, vertical,transversal or different axis and/or by rotational movement around anydirection. Plurality of applicators may move in synchronized, randomizedand/or independent manner. At least one applicator of the plurality ofapplicator may be static.

The homogeneity of treatment may be provided by the movement of theapplicator. In one exemplary embodiment the applicator may move overand/or in different angle to the patient by rotational movement. Inanother exemplary embodiment the applicator may move in the vicinity ofpatient's skin. In still another exemplary embodiment the applicator maymove to focus the treatment.

The movement of at least one applicator may provide a treatment pattern.The pattern may be, e.g. linear, wavy, circular, elliptical, zigzag,polygonal, oval, irregular and/or any combination thereof. In oneexemplary application the at least one applicator may be positioned tothe vicinity of thighs and the effect of treatment may be limited tothese parts. In another exemplary application the at least oneapplicator may be positioned over the patient's abdomen to treat e.g.adipose cells.

The movement of the applicator may also provide a treatment to largebody part, e.g. buttocks, abdomen or thigh.

The sensor may be connected with the hardware panel for controlling theoptical treatment to adjust the power flux density applied to thebiological structure to maintain the temperature of the targetbiological structure within treatment range. The temperature sensor alsoprevents the patient from any thermic damage.

Optical treatment may be used for remodeling, reducing the volume and/ornumber of adipose cells, body contouring or tightening skin, skinrejuvenation, wrinkles and/or stretch mark reduction, mole mark removal,tattoo removal, enhanced skin tightening, hair removal, treatment ofvascular lesions, acne treatment, sweating reduction and otherappearance improving and/or pain relief treatment without contacting theskin. The treatment may optionally be performed simultaneously orconsecutively during the same session.

The commonly targeted skin chromophores are hemoglobin, melanin, carbonor tattoo ink. Alternatively water may absorb the optical waves. Eachchromophore has unique absorption spectrum. The wavelength of theoptical wave should match one of the absorption peaks of the targetedchromophore. The lasers or laser diodes work usually in pulse regime inthese applications. The optical energy absorbed by the chromophore isconverted to thermal energy thereby destroying the targeted cells.Selection of the best adapted wavelength, power and pulse durationallows achieving optimal effect on targeted biological structure withminimal effect on surrounding tissue.

The application of optical treatment may be improved by application ofexogenous chromophores to the target biological structure. The exogenouschromophores may be applied in form of topical lotion, or may bedelivered to the target biological structure by micro-invasive orinvasive way such as injected.

According to the parameters of the optical waves used, different layersof the skin and different biological structures may be selectivelytreated. Various wavelengths, powers, pulse durations and repetitionrates of electromagnetic radiation are applicable to provide theadvantage of vast variability of penetration and absorption parameters.The operator may also adjust the optimum treatment time for eachwavelength and the time sequences of treatments by differentwavelengths, while some of them may overlap in time. In this way, atailor-made solution for each patient and each indication is available.The treatment may be highly selective to reduce or avoid damage of thesurrounding tissues.

Combinations of a plurality of optical waves generating devices allowperforming the treatment of plurality of target biological structures atthe same time and/or treating the same target tissue simultaneously bydifferent means, which optimizes the doses of radiation applied. Thisdiversification may also eliminate the risk of overheating, as theoptical treatment with parameters leading to no or negligible thermiceffect may be used. As a result, the risk of heat damage may beconsiderably reduced.

If the patient has more imperfections to be treated situated in the samebody areas, it is also possible to treat them simultaneously bydifferent types of electromagnetic waves. Each of the electromagneticwaves may be adjusted to optimum parameters for the target biologicalstructure imperfection treatment. Thus the time of patient and of theoperator is reduced, reducing the treatment cost.

The optical waves thermal effect may lead to temperature increase in thedermal and the sub dermal tissues also affects the triple-helixstructure of collagen fibers contained in such tissues. This may resultin remodeling and rejuvenation of collagen, increase of skin density anddermal thickening based on neocollagenesis. Skin tightening may also beachieved. In one aspect, the present methods selectively treat deephuman tissue containing low volume of water, such as adipose tissue.Optical energy is provided to the skin by optical waves generatingdevice. Remodeling and reducing the volume and/or number of adipocytesor skin tightening in the targeted areas may change the overallappearance of the body. Therefore it may be used for body contouring,body shaping and cellulite treatment.

Optical energy may be provided to the skin by at least one optical wavesgenerating device in pulse or continuous mode. Optical energy isprovided through the skin to the underlying dermal and/or subdermaltissue, without contacting the skin. The radiant energy may be convertedinside the target tissue to heat. The radiant energy enables treating ofthe adipose tissue and/or collagen tissue, accelerating apoptosis and/orcell lysis (e.g. adipose cell), based on amount of energy transmitted totarget biological structure. At the same time the triple helix structureof collagen fibers may result in remodeling and/or rejuvenation ofcollagen, increase of skin density and dermal thickening based onneocollagenesis. In an alternative embodiment the radiant energy enablestreating of target tissue resulting e.g. in neocollagenesis withoutadipose tissue reduction. Target tissue may be remodeled and/or reducedand body contouring and/or skin tightening effect may occur.

Cooling may also be used to modify and to optimally adjust the depth ofoptical radiation penetration. Light penetration may be enhanced ifcooling is used before phototherapy. The effects of heating in terms oflight penetration are the opposite.

Optical treatment may treat the same or different skin layers as themagnetic treatment. As mentioned above, optical treatment may also beused for multiple rejuvenation and appearance enhancing applications.Another important indication is drug-free and addiction-free pain reliefin many conditions.

Non-limiting examples of optical therapies that may be preferably usedin combination with the treatment by magnetic field according to thepresent invention are: low level light therapy (LLLT), photodynamictherapy (PDT), high power laser therapy (HPLT) or intense pulsed light(IPL). However, the scope of the invention is not limited only to theseparticular optical irradiation methods. Other electromagnetic waves maybe used, e.g. a radiofrequency treatment. The power flux density of theoptical wave therapy may be in the range to 0.1-100 W/cm², morepreferably in the range to 0.5-50 W/cm², most preferably 0.5-20 W/cm².

Low-level light therapy is one of the methods of non-invasiverejuvenation with no or a very small thermal effect. LLLT may beeffective throughout the visible, infrared and near ultraviolet spectrumranges. The term low level refers the fact that the levels of energy orpower densities are low compared to other forms of light treatment suchas by lasers, which are applicable for cutting, thermal coagulation orthermal damage, such as ablation. Treatment energies in LLLT are limitedto 0.1-20 or a few J/cm² and/or by a power of 1 mW to 500 mW per opticalwaves generating device. The depth of penetration of the low level lightradiation depends on parameters of the optical waves generating devicesuch as wavelength, operating mode, which may be pulse or continuous,the power output, the probe design and the treatment technique. Thedepth of penetration where the light still has therapeutic effectsshould match the depth of the desired zone to be treated. Thepenetration depth is lower than in HPTL, up to several tens of mmapproximately. Due to the low levels of absorbed energy, the treated andsurrounding biological structures are not heated and are not damaged.Although many wavelengths may be used, it is advantageous to use atleast one beam in the visible spectrum so that the area of applicationon the patient's body may be easily determined by the operator.

LLLT uses either coherent optical waves generating devices such aslasers or laser diodes or non-coherent light sources includingincandescent lamps, gas filled lamps, filtered lamps optimized for aparticular wavelength, light-emitting diodes, etc. A combination of anytypes of optical waves generating devices may be also used, as well as aplurality of optical waves generating devices of the same type.

The photons emitted by the low level optical waves generating devicesused in LLLT therapy may be absorbed by endogenous mitochondrialchromophores in skin. Consequently, many processes may be activated,e.g. electron transport, increased adenosine triphosphate (ATP)production, enhanced blood micro-circulation, collagen productionincrease, dermal matrix remodeling etc. LLLT may thus successfully treata multitude of conditions that require stimulation of healing,acute/chronic pain relief or restoration of function. LLLT hasbeneficial effects on wrinkles, scars including acne scars, stimulatingthe scalp in hair treatment, healing of burns, skin tightening,anti-oedematous effects, regeneration after sport etc. Inflammatory skindiseases such as psoriasis or acne may be also treated by the proposedtreatment. In pigmentation disorders such as vitiligo, LLLT may increasepigmentation by stimulating melanocyte proliferation.

LLLT may influence also reduction of number and/or volume of adiposecells. It is believed that the incident optical waves produce transientpores in adipose cells, allowing lipids to leak out into theinterstitial space of adipose tissue. If the parameters are appropriate,the pores close upon cessation of the energy application and the cellmembrane returns to contiguity. The adipose cells are not destroyed, buttemporary opening within the cell's membrane induced by the opticalwaves may provide a pathway for lipid to exit the cell and in the endalso the patient's body. It may leads to the reduction of number and/orvolume of adipose cells. This adipose cell number and/or volumereduction may restore proper adipose cells function thereby acting as ananti-diabetes mechanism.

It is advantageous to combine LLLT and magnetic treatment for safe andefficient target biological structure treatment.

While in LLLT the light is absorbed by endogenous cellular chromophores,PDT may be based on introduction of exogenous photosensitizers into thecells which are then irradiated with wavelengths of visible or nearinfra-red light. Photosensitizer drugs may become activated by one orseveral types of optical waves. The optimal type of optical wavesdepends on the target biological structure and the absorption peak ofthe particular chromophore drug used. PDT optical waves generatingdevices include laser, intense pulsed light, light-emitting diodes ormany visible lights including natural sunlight, etc.

Unlike LLLT HPLT has pronounced thermal effects on the skin. HPLT lasershaving an output of 500 mW or greater may be used for this treatment,with energy densities greater than 10 J/cm². High power allows extremelyhigh penetration of the optical waves, in order of ten centimeters oreven more, ensuring that the right dose actually reaches the targetbiological structure localized deep in the tissue. Laser may beprecisely adjusted due to its monochromacy and coherency. Therefore itspropagation and targeted biological structure may be finely pre-defined.Research shows that biological structures treated by HPLT are stimulatedto increase production of adenosine triphosphate (ATP). Similarly toLLLT, the biological responses to increased ATP production may includereduction of inflammation, reducing scars, increased cell metabolism,improved vascular activity, and accelerated healing. It may improveregeneration after sport. Significant improvements of manypost-traumatic pathologies or osteoarthritis have been noted, as well astemporary relief of stiffness and muscle spasms. It is important to notethat HPLT also may provide the patients with drug-free andaddiction-free acute and/or chronic mediation of pain, by decreasinginflammation and/or swelling and by increasing the release of endorphinsand enkephalins. Moreover, if a pulse regime is applied, thewavelength-specific photomechanical wave generated in the tissue maystimulate free nerve endings, thus blocking pain pathways in the nervoussystems and bringing immediate pain relief.

High power lasers, laser diodes or intense pulse light sources (IPL) maybe also used for treating pigmented targets in the skin by selectivephotothermolysis. Such high power lasers reaching sufficient powerdensity to vaporize illuminated cells may be gas lasers such as CO₂ orexcimer laser, solid-state lasers such as rubin, Nd:YAG or Er:YAG laser,semiconductor lasers, dye lasers such as Rhodamin 6G laser etc.

IPL may be used also for other skin treatments with therapeutic orrejuvenating effects, sharing some similarities with high power lasertreatment. In both cases, optical waves are used to destroy the target.But unlike lasers that use a single wavelength of light which typicallymatches only one chromophore, and hence only one condition, IPL uses abroad spectrum of wavelengths. When used with filters, it may be adaptedto treat various conditions. This may be achieved when the IPL operatorselects the appropriate filter that matches a specific chromophore. Suchfilter may be represented by an optical material filtering e.g. 480 nm,530 nm, 560 nm, 640 nm or 690 nm.

The optical energy flux density of the IPL treatment may be in the rangeof 1 and 50 J/cm², preferably in the range of 2 to 40 J/cm², morepreferably at least 5 J/cm2, or up to 100 J/cm². The optical waves maybe applied continually or in pulses. Pulse width is time duration thatthe target is exposed to the optical waves, it is measured inmiliseconds. Pulse width is shorter than thermal relaxation time of thetarget, i.e. the pulse width is long enough to allow heating of thetarget but also short enough that the target is able to cool so thatthere is no heat buildup in surrounding skin and tissue. The pulse widthmay be in the range of 1 to 300 ms, preferably in the range of 5 to 50ms, most preferably up to 30 ms.

Optical waves may penetrate the skin and increase the temperature ofadipose cells and thermally damage the adipose cells. Hence the opticaltreatment may be used for reducing number and/or volume of adiposecells, remodeling treated body parts, or improving the skin appearance.The target biological structure, e.g. adipose cells, may be exposed toincreased temperature. The temperature may be in the range of 37.5 to60° C., more preferably in the range of 40 to 50° C., most preferably inthe range of 42 to 47° C., or up 80° C. The damaged adipose cells may beremoved by blood and/or lymphatic system to be metabolized. The heatgenerated in the target biological structure may induce a production ofgrowth factors and/or fibroblasts which may improve collagen neogenesisand/or new vein formation to support the newly generated collagenformations.

Optimal wavelength should include low absorption within the skin, i.e.low absorption of water and/or melanin, and high absorption within theadipose cells. The optical waves may be in visible or in IR spectrumsuch as near-IR spectrum, e.g. in the range of 600 to 1500 nm in aplurality of applicable bands e.g. in the range of 635 to 680 nm,particularly 658 nm; or in the range of 780 to 980 nm, particularly 800nm or 940 nm; or in the range of 1050 to 1100 nm, particularly 1060 nmdue to relatively high penetration through the skin. Alternatively theoptical waves may be in the range of 1300 to 1450 nm, particularly 1320and 1440 nm may be applicable.

The optical treatment may last up to 120 minutes, preferably in therange of 1 to 60 minutes, more preferably in the range of 20 to 40minutes. The treatment time may be dependent on BMI of the patient. Thepower flux density of the optical treatment may be up to 50 W/cm²,preferably up to 25 W/cm², more preferably in the range of 1 to 15W/cm², most preferably in the range of 2 to 10 W/cm² such as at least 5W/cm2. In the preferred application power modulation may be used.

Optionally, active cooling may be included. However, in many cases, autothermoregulation by sweating is sufficient. The active cooling may beadministered in continual mode or in pulsed mode to maintain the skintemperature within physiologic temperature, i.e. around or below 37° C.

Alternatively, optical treatment by high power optical waves generatingdevice may be used for treatment of incontinence or menorrhagia. Oneexemplary application may be inserting the optical wave generatingdevice into the body cavity, e.g. a vagina, and treating the targetbiological structure by selectively heating. A suitable probe may beused for inserting the optical waves generating device. The targetbiological structure may be tightened due to increased temperatureand/or improved collagenesis. Alternatively the optical wave generatingdevice may be external to the body cavity and the optical waves may bedelivered to target tissue by optical delivery element.

An exemplary application of application combined treatment by opticalwaves and magnetic treatment may be application to enhancing appearanceof genitalia, e.g. external female genitalia such as labia minora, labiamajora and/or clitoris. Furthermore collagenesis may be improved invagina hence it may be smoother and/or firmer. Therefore the combinedtreatment may enhance physical pleasure during coitus.

Optimal wavelength of the optical waves may be in the range of 400 to600 nm, particularly around 500 nm. Energy density may be up to 25J/cm², more preferably up to 10 J/cm², most preferably in the range of 1to 8 J/cm². Treatment may be administered in continual or preferably inpulsed mode.

Alternatively, the application of optical waves may provide disinfectioneffect. Such application may include application of UV light, e.g. UV-Band/or UV-C light. The wavelength of the optical waves may be in therange of 200 to 300 nm, most preferably in the range of 250 to 270 nm.The optical radiation may destroy the DNA of microorganisms such asbacteria, or virus. The nucleic acid in DNA may form a covalent bond(such as thymine dimer) preventing unzipping process during reproductioncycle. Hence the replication ability of the microorganism is disabledand the microorganism may die and the infection may be treated. Thepower density may be up to 300 mW/cm2, preferably up to 200 mW/cm2, orin the range of 1 to 50 mW/cm2, more preferably in the range of 5 to 25mW/cm2 In one exemplary application the UV light may be in externalflow-chamber to provide disinfected air to the treated area.

Similar application of optical waves may be used for cleaning the skinof the patient.

The treatment by a combination of magnetic field and optical wavessignificantly improves the treatment effect. Most preferably, theoptical waves include wavelengths ranging from 405 to 1500 nm. At leastone optical waves generating device and at least one magnetic fieldgenerating device may be used.

The methods described are more gentle and efficient in adipose cellstreatment or skin tightening since the target biological structure istreated by magnetic and/or by electromagnetic field.

The application of magnetic and optical treatment may be used fortreatment of pelvic floor area disorders, e.g. gynaecologic and/orurologic issues such as incontinence. The magnetic treatment may betargeted to the area of pelvic floor to treat pelvic floor muscles. Therepetition rate of the magnetic pulses may be in the range of 1 to 150Hz, preferably up to 100 Hz, more preferably in the range of 5 to 70 Hz,e.g. at least 30 Hz. The optical treatment may selectively raise atemperature in the vagina to provide tightening effect. Alternativelythe optical treatment may provide biostimulation effect to promoteneocollagenesis. The tightening effect may be also promoted by at leastpartial muscle contraction. Hence the treatment of incontinence may beprovided by different energy types. The collagenesis may be improved byapplication of magnetic treatment improving local metabolism by improvedblood flow and/or at least partial muscle contraction.

Another application of magnetic and optical treatment may be used fortreating a pain. The pain relieving effect may be combined andsignificantly improved due to different applied energies and differentapproaches of relieving the pain. The pain relief is drug-free and maylast up to several hours after the treatment. The pain relieving may beapplied for treatment of chronic and/or acute pain. Alternatively, thepain relieving effect caused by magnetic and/or optical treatment may beused for improving acceptability of optical treatment provided by highpower density optical radiation, e.g. high power laser or IPL.

Still another application of magnetic and optical treatment may be usedfor causing relaxing effect. High efficient relaxation may be caused bycombined influence optical and magnetic treatment on the biologicalstructure.

Still another application of magnetic and optical treatment may be usedfor treating the adipose cells. The adipose cells may be heated by theoptical treatment above 37.5° C., more preferably above 40° C., mostpreferably in the range of 40 and 50° C., or up to 60° C. Thetemperature increase may induce apoptosis and/or necrosis of the adiposecells. The apoptosis of the adipose cells may be preferred effect due toreduced risk of inflammation and/or panniculitis occurrence. Thetemperature increase may also liquefy the adipose tissue. The magnetictreatment may contribute the optical treatment by inducing the at leastpartial muscle contraction which may improve the local blood and/orlymph circulation and/or local metabolism. Hence the death adipose cellsmay be removed faster from the human body. The apoptosis of the adiposecells may be also contributed by the influence of the magnetic treatmentto metabolism of Ca ions as was described before. The optical waves maybe in visible or in IR spectrum such as near-IR spectrum, e.g. in therange of 600 to 1500 nm in a plurality of applicable bands e.g. in therange of 635 to 680 nm, particularly 658 nm; or in the range of 780 to980 nm, particularly 800 nm or 940 nm; or in the range of 1050 to 1100nm, particularly 1060 nm due to relatively high penetration through theskin. Alternatively the optical waves may be in the range of 1300 to1450 nm, particularly 1320 and 1440 nm may be applicable.

The optical treatment may last up to 120 minutes, preferably in therange of 1 to 60 minutes, more preferably in the range of 20 to 40minutes. The treatment time may be dependent on BMI of the patient. Thepower flux density of the optical treatment may be up to 50 W/cm²,preferably up to 25 W/cm2, more preferably in the range of 1 to 15W/cm², most preferably in the range of 2 to 10 W/cm² such as at least 5W/cm². In the preferred application power modulation may be used.

Still another application of magnetic and optical treatment may be usedfor treating the cellulite. As was mentioned above the adipose cells maybe influenced by apoptosis and/or necrosis. Alternatively the adiposecells may be liquefied. The adipose cells metabolism may be contributedby the at least partial muscle contraction. Furthermore the applicationof optical treatment may heat the fibrous septae of the cellulite. Theheated septae may be straightened by the at least partial musclecontraction caused by the magnetic treatment. Further the at leastpartial muscle contraction may remove the water from the cellulitetissue to reduce the cellulite. Therefore more significant results maybe achieved in shorter time periods. The above mentioned methods may becombined hence the enhanced effect may be induced. Hence the results maybe achieved in shorted time period and may be more significant.

Still another application of magnetic and optical treatment may be usedfor enhancing body shape and/or improving muscle tonus to enhance visualappearance of the body part. According to one application, the musclemay be treated by the optical treatment to increase the temperature ofthe muscle. Afterwards the heated muscle may be treated by magnetictreatment. The magnetic treatment may achieve more significant resultsdue to increased temperature of the muscle. The muscle may be tonedand/or strengthened more effectively. The toned and/or strengthenedmuscle may induce body shaping effect to enhance visual appearance ofthe treated body part. Moreover the results may be achieved withouthours spent by exercising of the muscle which may achieve unpredictableresults within different body parts. The effectiveness of the magnetictreatment may be enhanced by preheating of the muscle by opticaltreatment. Magnetic treatment may be provided at repetition rate of atleast 0.1 Hz, more preferably at least 5 Hz, even more preferably atleast 20 Hz, most preferably at least 50 Hz, or up to 700 Hz. Themagnetic treatment may be preferably modulated.

Still another application of magnetic and optical treatment may be usedfor focused treating of specific muscle structures, e.g. buttocks. Thedemand for enhancing visual appearance of the buttocks has rapidlyincreased during last few years. The combined treatment may enhance thevisual appearance of the buttocks by thermal effect caused by opticaltreatment and/or by muscle exercising effect by focus magnetictreatment. The magnetic treatment may be selectively focus to enhancingthe visual appearance of the buttocks by shredding and/or toning of thebuttock muscles such as gluteus maximus, medius and/or minimus.

Alternatively, the combined focused treatment may be used for causingbreast lifting effect by preheating effect of the Cooper's ligament andfollowing magnetic treatment with increased effectiveness. The treatmentmay lift the breasts up.

Still another application of magnetic and optical treatment may be usedfor skin rejuvenation. The optical treatment may be applied to causemicro-damages within the skin to promote the increase production and/orregeneration of collagen fibers. It may induce the enhanced visualappearance of the skin which may look well-toned, smoother and/orfirmer. The optical treatment may be contributed by magnetic treatmentcausing at least partial muscle contraction which may induce theincrease local metabolism and/or blood circulation. Hence thesufficiency of nutrients may be delivered to the target biologicalstructure to promote its regeneration and/or production process.

Still another application of magnetic and optical treatment may be usedfor treating the wrinkles. The optical treatment may remove the wrinklesby resurfacing of the skin. Different wavelength may promote the growthof collagen and/or elastin fibers to provide the skin younger, firmerand/or smoother appearance. The optical treatment may be contributed bymagnetic treatment causing at least partial muscle contraction which mayinduce the increase local metabolism and/or blood circulation. Hence thesufficiency of nutrients may be delivered to the target biologicalstructure to promote its regeneration and/or production process.

The optical treatment may provide to the target biological structure theoptical waves of wavelength in the range of 500 to 3000 nm, severalwavelengths may be applicable for the treatment of wrinkles e.g. 590,640, 695, 800, 1320 or 2940 nm. Alternatively other wavelengths may bealso used. The energy delivered to the target biological structure maybe up to 50 J/cm², more preferably up to 25 J/cm², most preferably inthe range of 1 to 15 J/cm².

Still another application of magnetic and optical treatment may be usedfor treating the scars and/or stretchmarks. The optical treatment mayenhance the visual appearance of scars and/or stretchmarks by providingimproved the growth of collagen and/or elastin fibers to provide theskin younger, firmer and/or smoother appearance. The optical treatmentmay induce micro-damages to collagen and/or elastin fibers to promotetheir regeneration and/or production. The optical treatment may becontributed by magnetic treatment causing at least partial musclecontraction which may induce the increase local metabolism and/or bloodcirculation. Hence the sufficiency of nutrients may be delivered to thetarget biological structure to promote its regeneration and/orproduction process. Furthermore the at least partial muscle contractionmay straighten the newly produced collagen and/or elastin fibers bymassaging effect.

Still another application of magnetic and optical treatment may be usedfor lip visual appearance enhancing effect. The optical treatment mayimprove the growth of collagen and/or elastin fibers to provide younger,fuller, firmer and/or smoother appearance. The optical treatment may becontributed by magnetic treatment causing at least partial musclecontraction which may induce the increase local metabolism and/or bloodcirculation. Hence the sufficiency of nutrients may be delivered to thetarget biological structure to promote its regeneration and/orproduction process.

The above mentioned methods may be combined hence the enhanced effectmay be induced. Hence the results may be achieved in shorted time periodand may be more significant.

Optical treatment may be applied before the magnetic treatment. Theeffect of the optical treatment may be stimulating, e.g. increasing thetemperature of the target biological structure to prepare a targetbiological structure to be treated by magnetic treatment inducing atleast partial muscle contraction. To enhance the efficiency of thetreatment in some indications, it may be advantageous to preheat thetissue by infrared radiation prior to magnetic treatment or combinedmagnetic and optical treatment.

Alternatively the effect caused by optical treatment may increase thetemperature of the target biological structure, e.g. adipose cell orfibrous septae. It may be contributed by magnetic treatment causing atleast partial muscle contraction. The at least partial musclecontraction may provide a massage effect for biological structureswithin proximity of the target biological structure, improve the bloodand/or lymph circulation to improve local metabolism. Additionally theat least partial muscle contraction may reduce the number and/or volumeof the adipose cells by energy used for the at least partial musclecontraction itself. Moreover, homogenous temperature distribution may beprovided due to improved blood flow. Alternatively the at least partialmuscle contraction may provide massage effect for promoting movement offibrous septae.

Simultaneous application of combined magnetic and optical treatment mayreach more significant results than separate use of these treatments.

Simultaneous application of magnetic treatment and optical treatment maybe administered in two modes: a first mode may generate the magneticpulses while optical treatment is active or second mode may generatemagnetic pulses while the optical treatment is not in an activestimulation period, i.e. the period of magnetic treatment and opticaltreatment alternates.

The simultaneous application of magnetic treatment and optical treatmentto the target biological structure may increase the peak magneticcomponent of the entire treatment resulting in improved heating of thetarget biological structure containing higher water volume, e.g. skin.Alternatively, the level of polarization of the optical radiation may beincreased due to magnetic field, or a plane of polarization may rotate,e.g. Faraday's effect may occur. Due to increased temperature of skin,the production and/or remodeling of collagen and/or elastin fibers maybe improved and the skin may be provided with a younger, smoother andenhanced appearance. The effect of overheating the muscle is reduced bythe improved blood flow.

Optical treatment may also be used to attenuate the pain. Alternativelythe repetition rate of the magnetic treatment may attenuate pain aswell.

Optical treatment may be applied after the magnetic treatment to providecontributing effect such as analgesic effect or it may further improvelocal metabolism. The magnetic treatment may induce at least partialmuscle contraction or to stimulate a muscle structure to increase amuscular tonus of the target biological structure. Both effects mayprovide a massage effect for biological structures within the proximityof the target biological structure hence the blood and/or lymphcirculation may be improved to promote local metabolism. The temperaturemay be locally increased by the improved blood flow and the targetbiological structure may accept the following optical treatment atsignificantly higher efficiency. Hence the muscle may be heated athigher quality. Additionally, the collagen and/or elastin fibers may beremodeled or restored and/or its neogenesis may be improved to provide ayounger, smoother and enhanced skin appearance.

Additionally, previous application of magnetic treatment may improveacceptability of the optical treatment. The magnetic treatment mayprovide pain relieving effect for the biological structure hence thethermic effect caused by the optical treatment may be more tolerable forthe patient.

Another benefit may be releasing the adipose cells from the muscle by atleast partial muscle contraction and/or by temperature increase causingimproved metabolism of adipose cells. Still another benefit of the atleast partial muscle contraction may be mechanic breaking large adiposecells bulks into smaller bulks which may be easier removed by thelymphatic and/or blood flow. The liquidity of the smaller adipose bulksmay be contributed by application of optical treatment. Due to improvedliquidity, improved metabolism and/or blood circulation the cellulitemay be treated in a short time and the visual effect on skin appearancemay be significantly enhanced.

Optical radiation may be also used to attenuate the pain after themagnetic treatment.

Combined treatments may be applied to one target biological structure toprovide combined effect of magnetic and optical treatment. Alternativelythe treatment may be applied to different target biological structures,e.g. optical treatment may be applied to at least adipose cell andmagnetic treatment may be applied to at least one muscle fiber toimprove local and/or adipose cell metabolism.

All applications of combined magnetic and optical treatment may amplifythe resulting effect of the treatment. Therefore the results areachieved in significantly shorter time than the same results achieved byseparate applications of the optical and magnet treatments. Thetreatment may be provided in various predefined treatment protocolsfocused on specific patient's needs, e.g. cellulite treatment,incontinence treatment, pain relieving etc. Each treatment parameter maybe adjusted in the treatment protocol by the operator following thepatient's needs. Alternatively the specific treatment may be designed bythe operator for providing the most effective treatment following thepatient's needs.

A treatment device including a high frequency generator, a low frequencygenerator, a combiner and an energy deliver element; wherein the atleast one energy delivery element provides an electromagnetic treatmentand a magnetic treatment for treating a biological structure.

A treatment device including a least one high frequency generator, atleast one low frequency generator, a plurality of combiners and aplurality of energy deliver elements; wherein the plurality of energydelivery elements provides an electromagnetic treatment and a magnetictreatment for treating a biological structure.

A method of operating a treatment device comprising: generating a highfrequency signal; and generating a low frequency signal; and deliveringthe high frequency signal and/or the low frequency signal to an energydelivering element; and providing by the least one energy deliveryelement an electromagnetic and/or a magnetic treatment.

Magnetic stimulation device producing time-varying magnetic field fortreatment, wherein device comprises: a connection to an energy source, aswitch, a coil, an energy storage device, at least one blower and acasing; wherein the coil and the casing are arranged in a manner thatfluid can flow in-between and wherein the coil is cooled by fluid flowover at least upper and lower sides of the coil.

A method of patient's neural structure stimulation by time-varyingmagnetic field inducing an action potential and/or modulating the actionpotential, including: exposing the patient to a time-varying magneticfield with a repetition rate which exceeds a repetition rate resolutionof the target stimulated biological structure and wherein thetime-varying magnetic field generates an envelope including at least twopulses.

A method of operating a magnetic stimulation device including at leastone applicator, at least one energy source, a plurality of switchingdevices, at least one energy storage device and a plurality of magneticfield generating devices, comprising: generating a plurality of peaks ofmagnitudes of magnetic flux density using a plurality of magnetic fieldgenerating devices.

A treatment method for enhancing a visual appearance of a patient's bodyregion comprising: applying a time-varying magnetic field to a targetbiological structure in the body region to induce electric current inthe target biological structure, wherein the body region is at least oneof thighs, saddlebags, buttocks, abdomen, hips, torso, arms, breast,neck, face or lip of the patient.

Thus, novel systems and methods have been described. Various changes andsubstitutions may of course be made without departing from the spiritand scope of the invention. The invention, therefore, should not belimited, except by the following claims and their equivalents.

The following U.S. Patent Applications are incorporated herein byreference: Ser. Nos. 14/873,110; 14/926,365; 14/951,093; 15/073,318;15/099,274; 15/151,012; 15/178,455; 15/396,073; 15/446,951; 15/404,384and 15/473,390.

Thus, novel apparatus and methods have been shown and described. Variouschanges and substitutions may of course be made without departing fromthe spirit and scope of the invention. The invention, therefore, shouldnot be limited, except by the following claims and their equivalents.

What is claimed is:
 1. A device for treatment of a patient comprising: ahigh-frequency generator configured to generate a high-frequency signal,wherein the high-frequency signal is used for generating anelectromagnetic field; a circuit configured to generate a low-frequencysignal having a frequency in a range of 1 kHz to 100 kHz, the circuitcomprising: an energy storage device; and a switching device; whereinthe low-frequency signal is used for generating a time-varying magneticfield; and an applicator comprising: an energy delivery element coupledto the energy storage device and to the high-frequency generator;wherein the energy delivery element is configured to apply thetime-varying magnetic field to the patient at a repetition rate in arange of 1 Hz to 300 Hz to cause a muscle contraction; and wherein theenergy delivery element is configured to apply the electromagnetic fieldto heat a biological structure of the patient.
 2. The device of claim 1,wherein the high-frequency signal has a frequency in a range of 500 kHzto 3 GHz.
 3. The device of claim 1, wherein the energy delivery elementis a flat magnetic coil.
 4. The device of claim 1, wherein thetime-varying magnetic field has a magnetic flux density in a range of0.1 T to 7 T on the surface of the energy delivery element.
 5. Thedevice of claim 1, wherein the energy delivery element is configured toapply the time-varying magnetic field and the electromagnetic fieldsimultaneously.
 6. The device of claim 1, wherein the applicatorcomprises a temperature sensor.
 7. The device of claim 1, wherein theapplicator comprises a spacing object.
 8. A device for treatment of apatient comprising: a high-frequency generator configured to generate ahigh-frequency signal, wherein the high-frequency signal is used forgenerating of an electromagnetic field; a circuit configured to generatea low-frequency signal having a frequency in a range of 1 kHz to 100kHz, the circuit comprising: an energy storage device; and a switchingdevice; wherein the low-frequency signal is used for generating atime-varying magnetic field; a first energy delivery element coupled tothe circuit, wherein the first energy delivery element is configured toapply the time-varying magnetic field to the patient at a repetitionrate in a range of 1 Hz to 300 Hz to cause a muscle contraction; and asecond energy delivery element coupled to the high-frequency generator,wherein the second energy delivery element is configured to apply theelectromagnetic field to the patient to heat a biological structure. 9.The device of claim 8, further comprising: a first applicator comprisingthe first energy delivery element; and a second applicator comprisingthe second energy delivery element.
 10. The device of claim 8, furthercomprising an applicator, wherein the first energy delivery element andthe second energy delivery element are disposed within the applicator.11. The device of claim 10, wherein the second energy delivery elementis a coil.
 12. The device of claim 10, further comprising a filteringdevice, wherein the second energy delivery element is a radiofrequencyelectrode.
 13. The device of claim 12, wherein the filtering devicecomprises a capacitor.
 14. The device of claim 12, wherein the filteringdevice comprises a coil.
 15. The device of claim 8, wherein thehigh-frequency generator comprises an internal power source.
 16. Adevice for treatment of a patient comprising: a generator configured togenerate a low-frequency signal having a frequency in a range of 1 kHzto 100 kHz and a high-frequency signal having a frequency in a range of500 kHz to 3 GHz; wherein the low-frequency signal is used forgenerating a time-varying magnetic field having a repetition rate in arange of 1 Hz to 300 Hz; wherein the high-frequency signal is used forgenerating an electromagnetic field; and an applicator comprising: anenergy delivery element coupled to the generator; wherein the energydelivery element is configured to apply the time-varying magnetic fieldto cause a muscle contraction, and wherein the energy delivery elementis configured to apply the electromagnetic field to heat a biologicalstructure.
 17. The device of claim 16, further including a second energydelivery element providing a time-varying magnetic field causing amuscle contraction and an electromagnetic field causing heating of abiological structure.
 18. The device of claim 16, wherein the energydelivery element is a flat coil.
 19. The device of claim 16, wherein theenergy delivery element comprises a temperature sensor.
 20. The deviceof claim 16, wherein the time-varying magnetic field has a magnetic fluxdensity in a range of 0.1 T to 7 T on the surface of the energy deliveryelement.
 21. The device of claim 16, wherein the applicator comprises aspacing object.
 22. The device of claim 16, wherein the energy deliveryelement is configured to apply the time-varying magnetic field and theelectromagnetic field is simultaneously.
 23. The device of claim 16,further comprising a chair, wherein the chair comprises the applicator.24. A method of operating a treatment device for treatment of a patient,the method comprising: generating an electromagnetic field using ahigh-frequency signal; generating a time-varying magnetic field having arepetition rate in a range of 1 Hz to 300 Hz using a low-frequencysignal having a frequency in a range of 1 kHz to 100 kHz; delivering thehigh-frequency signal and the low-frequency signal to an energy deliveryelement; and providing the electromagnetic field to heat a biologicalstructure using the energy delivery element; and providing thetime-varying magnetic field to cause a muscle contraction using theenergy delivery element.
 25. The method of claim 24, wherein thetime-varying magnetic field and the electromagnetic field are providedsimultaneously.
 26. The method of claim 24, wherein the time-varyingmagnetic field and the electromagnetic field are provided separately.27. The method of claim 24, further comprising: generating thehigh-frequency signal using a high-frequency generator; and transferringthe high-frequency signal using a transmatch.
 28. The method of claim24, further comprising: generating the high-frequency signal using agenerator; and generating the low-frequency signal using the generator.29. The method of claim 24, wherein the high-frequency signal has afrequency in a range of 500 kHz to 3 GHz.
 30. The method of claim 24,further comprising cooling the skin of the patient using a spacingobject.